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Bioequivalence of Pramipexole Extended Release (PPX ER) 1.5mg x 1 Tablet Once Daily (q.d.) vs. PPX ER 0.375mg x 4 Tablets Under Fasted and Fed Conditions in Japanese Healthy Volunteers

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ClinicalTrials.gov Identifier: NCT01119443
Recruitment Status : Completed
First Posted : May 7, 2010
Results First Posted : June 27, 2011
Last Update Posted : June 9, 2014
Sponsor:
Information provided by:
Boehringer Ingelheim

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label)
Condition Healthy
Intervention Drug: PPX ER
Enrollment 28

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Treatment Sequence A Treatment Sequence B
Hide Arm/Group Description 1.5 mg x 1 tablet once daily (q.d.) fed -> 0.375 mg x 4 tablets q.d. fed -> 1.5 mg x 1 tablet q.d. fasted -> 0.375 mg x 4 tablets q.d. fasted 0.375 mg x 4 tablets q.d. fed -> 1.5 mg x 1 tablet q.d. fed -> 0.375 mg x 4 tablets q.d. fasted -> 1.5 mg x 1 tablet q.d. fasted
Period Title: Up-titration Period (10 Days)
Started 14 14
Completed 14 14
Not Completed 0 0
Period Title: Crossover Period 1 (5 Days)
Started 14 14
Completed 14 13
Not Completed 0 1
Reason Not Completed
Adverse Event             0             1
Period Title: Crossover Period 2 (5 Days)
Started 14 13
Completed 14 13
Not Completed 0 0
Period Title: Crossover Period 3 (5 Days)
Started 14 13
Completed 14 13
Not Completed 0 0
Period Title: Crossover Period 4 (5 Days)
Started 14 13
Completed 14 13
Not Completed 0 0
Period Title: Down-titration Period (1 Day)
Started 14 13
Completed 14 13
Not Completed 0 0
Period Title: End of Study (All Patients)
Started 14 14
Completed 14 14
Not Completed 0 0
Arm/Group Title Treatment Sequence A Treatment Sequence B Total
Hide Arm/Group Description 1.5 mg x 1 tablet q.d. fed -> 0.375 mg x 4 tablets q.d. fed -> 1.5 mg x 1 tablet q.d. fasted -> 0.375 mg x 4 tablets q.d. fasted 0.375 mg x 4 tablets q.d. fed -> 1.5 mg x 1 tablet q.d. fed -> 0.375 mg x 4 tablets q.d. fasted -> 1.5 mg x 1 tablet q.d. fasted Total of all reporting groups
Overall Number of Baseline Participants 14 14 28
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 14 participants 14 participants 28 participants
29.2  (4.8) 29.1  (5.4) 29.1  (5.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 14 participants 28 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
14
 100.0%
14
 100.0%
28
 100.0%
1.Primary Outcome
Title AUCτ,ss (Fed Conditions)
Hide Description Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ
Time Frame Serial pharmacokinetic blood samples collected before drug administration, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, and 23.833 hours after drug administration
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
One subject who discontinued the study on Day 1 of Visit 4 (the first day of the first crossover period) was excluded from Pharmacokinetic data set
Arm/Group Title Pramipexole ER 1.5 mg x 1 Tablet q.d. in Fed Pramipexole ER 0.375 mg x 4 Tablets q.d. in Fed
Hide Arm/Group Description:
Pramipexole ER 1.5 mg x 1 tablet once a day (q.d.) under fed conditions
Pramipexole ER 0.375 mg x 4 tablets once a day (q.d.) under fed conditions
Overall Number of Participants Analyzed 27 27
Geometric Mean (Standard Deviation)
Unit of Measure: ng·h/mL
33.7  (5.89) 32.3  (5.89)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pramipexole ER 1.5 mg x 1 Tablet q.d. in Fed, Pramipexole ER 0.375 mg x 4 Tablets q.d. in Fed
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Bioequivalence between pramipexole ER 1.5 mg x 1 tablet q.d. and pramipexole ER 0.375 mg x 4 tablets q.d. in fed condition
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Test/Reference Ratio of the mean x 100
Estimated Value 104.2
Confidence Interval (2-Sided) 90%
98.3 to 110.3
Estimation Comments Bioequivalence is established when 90% Confidence Interval falls within 80 - 125
2.Primary Outcome
Title Cmax,ss (Fed Conditions)
Hide Description maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ
Time Frame Serial pharmacokinetic blood samples collected before drug administration, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, and 23.833 hours after drug administration
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
One subject who discontinued the study on Day 1 of Visit 4 (the first day of the first crossover period) was excluded from Pharmacokinetic data set
Arm/Group Title Pramipexole ER 1.5 mg x 1 Tablet q.d. in Fed Pramipexole ER 0.375 mg x 4 Tablets q.d. in Fed
Hide Arm/Group Description:
Pramipexole ER 1.5 mg x 1 tablet once a day (q.d.) under fed conditions
Pramipexole ER 0.375 mg x 4 tablets once a day (q.d.) under fed conditions
Overall Number of Participants Analyzed 27 27
Geometric Mean (Standard Deviation)
Unit of Measure: ng/mL
2.24  (0.290) 2.13  (0.255)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pramipexole ER 1.5 mg x 1 Tablet q.d. in Fed, Pramipexole ER 0.375 mg x 4 Tablets q.d. in Fed
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Bioequivalence between pramipexole ER 1.5 mg x 1 tablet q.d. and pramipexole ER 0.375 mg x 4 tablets q.d. in fed condition
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Test/Reference Ratio of the mean x 100
Estimated Value 104.8
Confidence Interval 90%
100.1 to 109.8
Estimation Comments Bioequivalence is established when 90% Confidence Interval falls within 80 - 125
3.Primary Outcome
Title AUCτ,ss (Fasted Conditions)
Hide Description Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ
Time Frame Serial pharmacokinetic blood samples collected before drug administration, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, and 23.833 hours after drug administration
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
One subject who discontinued the study on Day 1 of Visit 4 (the first day of the first crossover period) was excluded from Pharmacokinetic data set
Arm/Group Title Pramipexole ER 1.5 mg x 1 Tablet q.d. in Fasted Pramipexole ER 0.375 mg x 4 Tablets q.d. in Fasted
Hide Arm/Group Description:
Pramipexole ER 1.5 mg x 1 tablet once a day (q.d.) under fasted conditions
Pramipexole ER 0.375 mg x 4 tablets once a day (q.d.) under fasted conditions
Overall Number of Participants Analyzed 27 27
Geometric Mean (Standard Deviation)
Unit of Measure: ng/mL
31.4  (7.37) 33.6  (5.80)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pramipexole ER 1.5 mg x 1 Tablet q.d. in Fasted, Pramipexole ER 0.375 mg x 4 Tablets q.d. in Fasted
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Bioequivalence between pramipexole ER 1.5 mg x 1 tablet q.d. and pramipexole ER 0.375 mg x 4 tablets q.d. in fasted condition
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Test/Reference Ratio of the mean x 100
Estimated Value 93.6
Confidence Interval 90%
86.9 to 100.8
Estimation Comments Bioequivalence is established when 90% Confidence Interval falls within 80 - 125
4.Primary Outcome
Title Cmax,ss (Fasted Conditions)
Hide Description maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ
Time Frame Serial pharmacokinetic blood samples collected before drug administration, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, and 23.833 hours after drug administration
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
One subject who discontinued the study on Day 1 of Visit 4 (the first day of the first crossover period) was excluded from Pharmacokinetic data set
Arm/Group Title Pramipexole ER 1.5 mg x 1 Tablet q.d. in Fasted Pramipexole ER 0.375 mg x 4 Tablets q.d. in Fasted
Hide Arm/Group Description:
Pramipexole ER 1.5 mg x 1 tablet once a day (q.d.) under fasted conditions
Pramipexole ER 0.375 mg x 4 tablets once a day (q.d.) under fasted conditions
Overall Number of Participants Analyzed 27 27
Geometric Mean (Standard Deviation)
Unit of Measure: ng/mL
2.13  (0.359) 2.12  (0.305)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pramipexole ER 1.5 mg x 1 Tablet q.d. in Fasted, Pramipexole ER 0.375 mg x 4 Tablets q.d. in Fasted
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Bioequivalence between pramipexole ER 1.5 mg x 1 tablet q.d. and pramipexole ER 0.375 mg x 4 tablets q.d. in fasted condition
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Test/Reference Ratio of the mean x 100
Estimated Value 100.2
Confidence Interval (2-Sided) 90%
94.0 to 106.7
Estimation Comments Bioequivalence is established when 90% Confidence Interval falls within 80 - 125
5.Secondary Outcome
Title Cτ,ss (Fed Conditions)
Hide Description Concentration of the analyte in plasma at time τ at steady state
Time Frame pharmacokinetic blood samples collected at τ (23.833 hours) after drug administration
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
One subject who discontinued the study on Day 1 of Visit 4 (the first day of the first crossover period) was excluded from Pharmacokinetic data set
Arm/Group Title Pramipexole ER 1.5 mg x 1 Tablet q.d. in Fed Pramipexole ER 0.375 mg x 4 Tablets q.d. in Fed
Hide Arm/Group Description:
Pramipexole ER 1.5 mg x 1 tablet once a day (q.d.) under fed conditions
Pramipexole ER 0.375 mg x 4 tablets once a day (q.d.) under fed conditions
Overall Number of Participants Analyzed 27 27
Geometric Mean (Standard Error)
Unit of Measure: ng/mL
0.711  (0.184) 0.656  (0.217)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pramipexole ER 1.5 mg x 1 Tablet q.d. in Fed, Pramipexole ER 0.375 mg x 4 Tablets q.d. in Fed
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Bioequivalence between pramipexole ER 1.5 mg x 1 tablet q.d. and pramipexole ER 0.375 mg x 4 tablets q.d. in fed condition
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Test/Reference Ratio of the mean x 100
Estimated Value 108.31
Confidence Interval (2-Sided) 90%
95.634 to 122.676
Estimation Comments Bioequivalence is established when 90% Confidence Interval falls within 80 - 125
6.Secondary Outcome
Title Cmin,ss (Fed Conditions)
Hide Description Minimum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ
Time Frame Serial pharmacokinetic blood samples collected before drug administration, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, and 23.833 hours after drug administration
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
One subject who discontinued the study on Day 1 of Visit 4 (the first day of the first crossover period) was excluded from Pharmacokinetic data set
Arm/Group Title Pramipexole ER 1.5 mg x 1 Tablet q.d. in Fed Pramipexole ER 0.375 mg x 4 Tablets q.d. in Fed
Hide Arm/Group Description:
Pramipexole ER 1.5 mg x 1 tablet once a day (q.d.) under fed conditions
Pramipexole ER 0.375 mg x 4 tablets once a day (q.d.) under fed conditions
Overall Number of Participants Analyzed 27 27
Geometric Mean (Standard Deviation)
Unit of Measure: ng/mL
0.676  (0.195) 0.633  (0.218)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pramipexole ER 1.5 mg x 1 Tablet q.d. in Fed, Pramipexole ER 0.375 mg x 4 Tablets q.d. in Fed
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Bioequivalence between pramipexole ER 1.5 mg x 1 tablet q.d. and pramipexole ER 0.375 mg x 4 tablets q.d. in fed condition
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Test/Reference Ratio of the mean x 100
Estimated Value 106.85
Confidence Interval (2-Sided) 90%
93.189 to 122.251
Estimation Comments Bioequivalence is established when 90% Confidence Interval falls within 80 - 125
7.Secondary Outcome
Title Tmax,ss (Fed Conditions)
Hide Description Time from dosing to the maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ
Time Frame Serial pharmacokinetic blood samples collected before drug administration, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, and 23.833 hours after drug administration
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
One subject who discontinued the study on Day 1 of Visit 4 (the first day of the first crossover period) was excluded from Pharmacokinetic data set
Arm/Group Title Pramipexole ER 1.5 mg x 1 Tablet q.d. in Fed Pramipexole ER 0.375 mg x 4 Tablets q.d. in Fed
Hide Arm/Group Description:
Pramipexole ER 1.5 mg x 1 tablet once a day (q.d.) under fed conditions
Pramipexole ER 0.375 mg x 4 tablets once a day (q.d.) under fed conditions
Overall Number of Participants Analyzed 27 27
Mean (Full Range)
Unit of Measure: hour
5.67
(2.00 to 10.00)
5.76
(2.00 to 10.00)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pramipexole ER 1.5 mg x 1 Tablet q.d. in Fed, Pramipexole ER 0.375 mg x 4 Tablets q.d. in Fed
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Bioequivalence between pramipexole ER 1.5 mg x 1 tablet q.d. and pramipexole ER 0.375 mg x 4 tablets q.d. in fed condition
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Test/Reference Ratio of the mean x 100
Estimated Value 98.426
Confidence Interval (2-Sided) 90%
84.276 to 112.58
Estimation Comments Bioequivalence is established when 90% Confidence Interval falls within 80 - 125
8.Secondary Outcome
Title λz,ss (Fed Conditions)
Hide Description Terminal rate constant of the analyte in plasma at steady state
Time Frame Serial pharmacokinetic blood samples collected before drug administration, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, and 23.833 hours after drug administration
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
One subject who discontinued the study on Day 1 of Visit 4 (the first day of the first crossover period) was excluded from Pharmacokinetic data set
Arm/Group Title Pramipexole ER 1.5 mg x 1 Tablet q.d. in Fed Pramipexole ER 0.375 mg x 4 Tablets q.d. in Fed
Hide Arm/Group Description:
Pramipexole ER 1.5 mg x 1 tablet once a day (q.d.) under fed conditions
Pramipexole ER 0.375 mg x 4 tablets once a day (q.d.) under fed conditions
Overall Number of Participants Analyzed 27 27
Geometric Mean (Standard Deviation)
Unit of Measure: per hour
0.0609  (0.0170) 0.0640  (0.0169)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pramipexole ER 1.5 mg x 1 Tablet q.d. in Fed, Pramipexole ER 0.375 mg x 4 Tablets q.d. in Fed
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Bioequivalence between pramipexole ER 1.5 mg x 1 tablet q.d. and pramipexole ER 0.375 mg x 4 tablets q.d. in fed condition
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Test/Reference Ratio of the mean x 100
Estimated Value 95.11
Confidence Interval (2-Sided) 90%
82.461 to 109.698
Estimation Comments Bioequivalence is established when 90% Confidence Interval falls within 80 - 125
9.Secondary Outcome
Title t1/2,ss (Fed Conditions)
Hide Description Terminal half-life of the analyte in plasma at steady state
Time Frame Serial pharmacokinetic blood samples collected before drug administration, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, and 23.833 hours after drug administration
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
One subject who discontinued the study on Day 1 of Visit 4 (the first day of the first crossover period) was excluded from Pharmacokinetic data set
Arm/Group Title Pramipexole ER 1.5 mg x 1 Tablet q.d. in Fed Pramipexole ER 0.375 mg x 4 Tablets q.d. in Fed
Hide Arm/Group Description:
Pramipexole ER 1.5 mg x 1 tablet once a day (q.d.) under fed conditions
Pramipexole ER 0.375 mg x 4 tablets once a day (q.d.) under fed conditions
Overall Number of Participants Analyzed 27 27
Geometric Mean (Standard Deviation)
Unit of Measure: hour
11.4  (5.02) 10.8  (6.01)
10.Secondary Outcome
Title MRTpo,ss (Fed Conditions)
Hide Description Mean residence time of the analyte in the body at steady state after oral administration
Time Frame Serial pharmacokinetic blood samples collected before drug administration, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, and 23.833 hours after drug administration
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
One subject who discontinued the study on Day 1 of Visit 4 (the first day of the first crossover period) was excluded from Pharmacokinetic data set
Arm/Group Title Pramipexole ER 1.5 mg x 1 Tablet q.d. in Fed Pramipexole ER 0.375 mg x 4 Tablets q.d. in Fed
Hide Arm/Group Description:
Pramipexole ER 1.5 mg x 1 tablet once a day (q.d.) under fed conditions
Pramipexole ER 0.375 mg x 4 tablets once a day (q.d.) under fed conditions
Overall Number of Participants Analyzed 27 27
Geometric Mean (Standard Deviation)
Unit of Measure: hour
19.1  (6.08) 18.4  (7.60)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pramipexole ER 1.5 mg x 1 Tablet q.d. in Fed, Pramipexole ER 0.375 mg x 4 Tablets q.d. in Fed
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Bioequivalence between pramipexole ER 1.5 mg x 1 tablet q.d. and pramipexole ER 0.375 mg x 4 tablets q.d. in fed condition
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Test/Reference Ratio of the mean x 100
Estimated Value 104.07
Confidence Interval (2-Sided) 90%
91.585 to 118.263
Estimation Comments Bioequivalence is established when 90% Confidence Interval falls within 80 - 125
11.Secondary Outcome
Title Cτ,ss (Fasted Conditions)
Hide Description Concentration of the analyte in plasma at time τ at steady state
Time Frame pharmacokinetic blood samples collected at τ (23.833 hours) after drug administration
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
One subject who discontinued the study on Day 1 of Visit 4 (the first day of the first crossover period) was excluded from Pharmacokinetic data set
Arm/Group Title Pramipexole ER 1.5 mg x 1 Tablet q.d. in Fasted Pramipexole ER 0.375 mg x 4 Tablets q.d. in Fasted
Hide Arm/Group Description:
Pramipexole ER 1.5 mg x 1 tablet once a day (q.d.) under fasted conditions
Pramipexole ER 0.375 mg x 4 tablets once a day (q.d.) under fasted conditions
Overall Number of Participants Analyzed 27 27
Geometric Mean (Standard Error)
Unit of Measure: ng/mL
0.654  (0.342) 0.757  (0.283)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pramipexole ER 1.5 mg x 1 Tablet q.d. in Fasted, Pramipexole ER 0.375 mg x 4 Tablets q.d. in Fasted
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Bioequivalence between pramipexole ER 1.5 mg x 1 tablet q.d. and pramipexole ER 0.375 mg x 4 tablets q.d. in fasted condition
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Test/Reference Ratio of the mean x 100
Estimated Value 86.57
Confidence Interval (2-Sided) 90%
73.583 to 101.854
Estimation Comments Bioequivalence is established when 90% Confidence Interval falls within 80 - 125
12.Secondary Outcome
Title Cmin,ss (Fasted Conditions)
Hide Description Minimum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ
Time Frame Serial pharmacokinetic blood samples collected before drug administration, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, and 23.833 hours after drug administration
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
One subject who discontinued the study on Day 1 of Visit 4 (the first day of the first crossover period) was excluded from Pharmacokinetic data set
Arm/Group Title Pramipexole ER 1.5 mg x 1 Tablet q.d. in Fasted Pramipexole ER 0.375 mg x 4 Tablets q.d. in Fasted
Hide Arm/Group Description:
Pramipexole ER 1.5 mg x 1 tablet once a day (q.d.) under fasted conditions
Pramipexole ER 0.375 mg x 4 tablets once a day (q.d.) under fasted conditions
Overall Number of Participants Analyzed 27 27
Geometric Mean (Standard Deviation)
Unit of Measure: ng/mL
0.654  (0.342) 0.757  (0.283)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pramipexole ER 1.5 mg x 1 Tablet q.d. in Fasted, Pramipexole ER 0.375 mg x 4 Tablets q.d. in Fasted
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Bioequivalence between pramipexole ER 1.5 mg x 1 tablet q.d. and pramipexole ER 0.375 mg x 4 tablets q.d. in fasted condition
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Test/Reference Ratio of the mean x 100
Estimated Value 86.57
Confidence Interval (2-Sided) 90%
73.583 to 101.854
Estimation Comments Bioequivalence is established when 90% Confidence Interval falls within 80 - 125
13.Secondary Outcome
Title Tmax,ss (Fasted Conditions)
Hide Description Time from dosing to the maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ
Time Frame Serial pharmacokinetic blood samples collected before drug administration, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, and 23.833 hours after drug administration
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
One subject who discontinued the study on Day 1 of Visit 4 (the first day of the first crossover period) was excluded from Pharmacokinetic data set
Arm/Group Title Pramipexole ER 1.5 mg x 1 Tablet q.d. in Fasted Pramipexole ER 0.375 mg x 4 Tablets q.d. in Fasted
Hide Arm/Group Description:
Pramipexole ER 1.5 mg x 1 tablet once a day (q.d.) under fasted conditions
Pramipexole ER 0.375 mg x 4 tablets once a day (q.d.) under fasted conditions
Overall Number of Participants Analyzed 27 27
Mean (Full Range)
Unit of Measure: hour
4.24
(2.00 to 8.00)
4.28
(2.50 to 8.00)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pramipexole ER 1.5 mg x 1 Tablet q.d. in Fasted, Pramipexole ER 0.375 mg x 4 Tablets q.d. in Fasted
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Bioequivalence between pramipexole ER 1.5 mg x 1 tablet q.d. and pramipexole ER 0.375 mg x 4 tablets q.d. in fasted condition
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Test/Reference Ratio of the mean x 100
Estimated Value 99.069
Confidence Interval (2-Sided) 90%
80.688 to 117.45
Estimation Comments Bioequivalence is established when 90% Confidence Interval falls within 80 - 125
14.Secondary Outcome
Title λz,ss (Fasted Conditions)
Hide Description Terminal rate constant of the analyte in plasma at steady state
Time Frame Serial pharmacokinetic blood samples collected before drug administration, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, and 23.833 hours after drug administration
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
One subject who discontinued the study on Day 1 of Visit 4 (the first day of the first crossover period) was excluded from Pharmacokinetic data set
Arm/Group Title Pramipexole ER 1.5 mg x 1 Tablet q.d. in Fasted Pramipexole ER 0.375 mg x 4 Tablets q.d. in Fasted
Hide Arm/Group Description:
Pramipexole ER 1.5 mg x 1 tablet once a day (q.d.) under fasted conditions
Pramipexole ER 0.375 mg x 4 tablets once a day (q.d.) under fasted conditions
Overall Number of Participants Analyzed 27 27
Geometric Mean (Standard Deviation)
Unit of Measure: /hour
0.0520  (0.0275) 0.0474  (0.0239)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pramipexole ER 1.5 mg x 1 Tablet q.d. in Fasted, Pramipexole ER 0.375 mg x 4 Tablets q.d. in Fasted
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Bioequivalence between pramipexole ER 1.5 mg x 1 tablet q.d. and pramipexole ER 0.375 mg x 4 tablets q.d. in fasted condition
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Test/Reference Ratio of the mean x 100
Estimated Value 109.48
Confidence Interval (2-Sided) 90%
89.571 to 133.811
Estimation Comments Bioequivalence is established when 90% Confidence Interval falls within 80 - 125
15.Secondary Outcome
Title t1/2,ss (Fasted Conditions)
Hide Description Terminal half-life of the analyte in plasma at steady state
Time Frame Serial pharmacokinetic blood samples collected before drug administration, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, and 23.833 hours after drug administration
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
One subject who discontinued the study on Day 1 of Visit 4 (the first day of the first crossover period) was excluded from Pharmacokinetic data set
Arm/Group Title Pramipexole ER 1.5 mg x 1 Tablet q.d. in Fasted Pramipexole ER 0.375 mg x 4 Tablets q.d. in Fasted
Hide Arm/Group Description:
Pramipexole ER 1.5 mg x 1 tablet once a day (q.d.) under fasted conditions
Pramipexole ER 0.375 mg x 4 tablets once a day (q.d.) under fasted conditions
Overall Number of Participants Analyzed 27 27
Geometric Mean (Standard Deviation)
Unit of Measure: hour
13.3  (9.82) 14.6  (10.8)
16.Secondary Outcome
Title MRTpo,ss (Fasted Conditions)
Hide Description Mean residence time of the analyte in the body at steady state after oral administration
Time Frame Serial pharmacokinetic blood samples collected before drug administration, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, and 23.833 hours after drug administration
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Hide Analysis Population Description
One subject who discontinued the study on Day 1 of Visit 4 (the first day of the first crossover period) was excluded from Pharmacokinetic data set
Arm/Group Title Pramipexole ER 1.5 mg x 1 Tablet q.d. in Fasted Pramipexole ER 0.375 mg x 4 Tablets q.d. in Fasted
Hide Arm/Group Description:
Pramipexole ER 1.5 mg x 1 tablet once a day (q.d.) under fasted conditions
Pramipexole ER 0.375 mg x 4 tablets once a day (q.d.) under fasted conditions
Overall Number of Participants Analyzed 27 27
Geometric Mean (Standard Deviation)
Unit of Measure: hour
21.2  (13.1) 22.9  (13.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pramipexole ER 1.5 mg x 1 Tablet q.d. in Fasted, Pramipexole ER 0.375 mg x 4 Tablets q.d. in Fasted
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Bioequivalence between pramipexole ER 1.5 mg x 1 tablet q.d. and pramipexole ER 0.375 mg x 4 tablets q.d. in fasted condition
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Test/Reference Ratio of the mean x 100
Estimated Value 92.63
Confidence Interval (2-Sided) 90%
77.871 to 110.185
Estimation Comments Bioequivalence is established when 90% Confidence Interval falls within 80 - 125
Time Frame 32 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Up-titration 1.5 mg q.d. Fed 1.5 mg q.d. Fast
Hide Arm/Group Description Up-titration to 0.75mg (10 days) 1.5 mg x 1 tablet q.d. or 0.375 mg x 4 tablets q.d. in fed condition (10days in crossover) 1.5 mg x 1 tablet q.d. or 0.375 mg x 4 tablets q.d. in fast condition (10 days in crossover)
All-Cause Mortality
Up-titration 1.5 mg q.d. Fed 1.5 mg q.d. Fast
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Up-titration 1.5 mg q.d. Fed 1.5 mg q.d. Fast
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/28 (0.00%)   0/28 (0.00%)   0/27 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Up-titration 1.5 mg q.d. Fed 1.5 mg q.d. Fast
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   5/28 (17.86%)   5/28 (17.86%)   0/27 (0.00%) 
Gastrointestinal disorders       
Epigastric discomfort  1  1/28 (3.57%)  2/28 (7.14%)  0/27 (0.00%) 
Nausea  1  0/28 (0.00%)  2/28 (7.14%)  0/27 (0.00%) 
Nervous system disorders       
Somnolence  1  4/28 (14.29%)  2/28 (7.14%)  0/27 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 13.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.
Results Point of Contact
Name/Title: Boehringer Ingelheim Call Center
Organization: Boehringer Ingelheim Pharmaceuticals
Phone: 1-800-243-0127
Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01119443     History of Changes
Other Study ID Numbers: 248.677
First Submitted: May 5, 2010
First Posted: May 7, 2010
Results First Submitted: May 30, 2011
Results First Posted: June 27, 2011
Last Update Posted: June 9, 2014