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Trial record 58 of 948 for:    tablet | Japan

Bioequivalence Study of Telmisartan Between Telmisartan 80 mg/Amlodipine 5 mg FDC Tablet and Telmisartan 80 mg Tab and Amlodipine 5 mg Tab Concomitant Use

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ClinicalTrials.gov Identifier: NCT01344629
Recruitment Status : Completed
First Posted : April 29, 2011
Results First Posted : August 27, 2012
Last Update Posted : March 28, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label)
Condition Healthy
Interventions Drug: Telmisartan/Amlodipin FDC
Drug: Telmisartan
Drug: Amlodipin
Enrollment 64
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Treatment Sequence A Treatment Sequence B
Hide Arm/Group Description T80/A 5mg FDC tablet, Concomitant use, Concomitant use, T80/A 5mg FDC tablet Concomitant use, T80/A 5mg FDC tablet, T80/A 5mg FDC tablet, Concomitant use
Period Title: Crossover Period 1
Started 32 32
Completed 32 32
Not Completed 0 0
Period Title: Crossover Period 2
Started 32 32
Completed 32 31
Not Completed 0 1
Reason Not Completed
Withdrawal by Subject             0             1
Period Title: Crossover Period 3
Started 32 31
Completed 32 31
Not Completed 0 0
Period Title: Crossover Period 4
Started 32 31
Completed 32 31
Not Completed 0 0
Arm/Group Title Treatment Sequence A Treatment Sequence B Total
Hide Arm/Group Description [Not Specified] [Not Specified] Total of all reporting groups
Overall Number of Baseline Participants 32 32 64
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Year
Number Analyzed 32 participants 32 participants 64 participants
24.1  (3.3) 24.5  (3.8) 24.3  (3.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 32 participants 32 participants 64 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
32
 100.0%
32
 100.0%
64
 100.0%
1.Primary Outcome
Title AUC0-tz
Hide Description Area under the concentration-time curve of Telmisartan in plasma over the time interval from 0 to the time of the last quantifiable data point
Time Frame Serial pharmacokinetic blood samples collected before drug administration, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours after drug administration
Hide Outcome Measure Data
Hide Analysis Population Description
One subject who discontinued the study on period 2 was excluded from Pharmacokinetic data set. Therefore, the number of observed PK parameter were 32+32+31+31=126 in T80/A5 FDC tablet and T80 + A5, respectively.
Arm/Group Title T80/A5 mg FDC Tablet T80mg Tablet and A5 mg Tablet in Concomitant Use
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 126 126
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng*hour/mL
1970
(67.9%)
1950
(67.0%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection T80/A5 mg FDC Tablet, T80mg Tablet and A5 mg Tablet in Concomitant Use
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Bioequivalence between T80/A 5mg FDC tablet and T80mg / A5 mg tablet in concomitant use
Statistical Test of Hypothesis P-Value [Not Specified]
Comments No statistical test
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Test/Reference Ratio of the mean x 100
Estimated Value 100.9
Confidence Interval 90%
97.7 to 104.2
Estimation Comments [Not Specified]
2.Primary Outcome
Title Cmax
Hide Description maximum measured concentration of Telmisartan in plasma
Time Frame Serial pharmacokinetic blood samples collected before drug administration, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours after drug administration
Hide Outcome Measure Data
Hide Analysis Population Description
One subject who discontinued the study on period 2 was excluded from Pharmacokinetic data set. Therefore, the number of observed PK parameter were 32+32+31+31=126 in T80/A5 FDC tablet and T80 + A5, respectively.
Arm/Group Title T80/A5 mg FDC Tablet T80mg Tablet and A5 mg Tablet in Concomitant Use
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 126 126
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng/mL
471
(88.1%)
484
(81.8%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection T80/A5 mg FDC Tablet, T80mg Tablet and A5 mg Tablet in Concomitant Use
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Bioequivalence between T80/A 5mg FDC tablet and T80mg / A5 mg tablet in concomitant use
Statistical Test of Hypothesis P-Value [Not Specified]
Comments No statistical test
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Test/Reference Ratio of the mean x 100
Estimated Value 97.2
Confidence Interval 90%
87.2 to 108.3
Estimation Comments [Not Specified]
3.Secondary Outcome
Title AUC0-∞
Hide Description area under the concentration-time curve of Telmisartan in plasma over the time interval from 0 extrapolated to infinity
Time Frame Serial pharmacokinetic blood samples collected before drug administration, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours after drug administration
Hide Outcome Measure Data
Hide Analysis Population Description
One subject who discontinued the study on period 2 was excluded from Pharmacokinetic data set. In analysis only used data which the parameter can be calculated.
Arm/Group Title T80/A5 mg FDC Tablet T80mg Tablet and A5 mg Tablet in Concomitant Use
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 110 112
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng*hour/mL
2410
(60.4%)
2300
(62.4%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection T80/A5 mg FDC Tablet, T80mg Tablet and A5 mg Tablet in Concomitant Use
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Bioequivalence between T80/A 5mg FDC tablet and T80mg / A5 mg tablet in concomitant use
Statistical Test of Hypothesis P-Value [Not Specified]
Comments No statistical test
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Test/Reference Ratio of the mean x 100
Estimated Value 101.7
Confidence Interval 90%
98.3 to 105.2
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Tmax
Hide Description time from dosing to the maximum concentration of Telmisartan in plasma
Time Frame Serial pharmacokinetic blood samples collected before drug administration, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours after drug administration
Hide Outcome Measure Data
Hide Analysis Population Description
One subject who discontinued the study on period 2 was excluded from Pharmacokinetic data set. Therefore, the number of observed PK parameter were 32+32+31+31=126 in T80/A5 FDC tablet and T80 + A5, respectively.
Arm/Group Title T80/A5 mg FDC Tablet T80mg Tablet and A5 mg Tablet in Concomitant Use
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 126 126
Mean (Full Range)
Unit of Measure: hour
0.750
(0.500 to 4.00)
0.750
(0.250 to 4.00)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection T80/A5 mg FDC Tablet, T80mg Tablet and A5 mg Tablet in Concomitant Use
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Bioequivalence between T80/A 5mg FDC tablet and T80mg / A5 mg tablet in concomitant use
Statistical Test of Hypothesis P-Value [Not Specified]
Comments No statistical test
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Test/Reference Ratio of the mean x 100
Estimated Value 110.1
Confidence Interval 90%
95.8 to 124.4
Estimation Comments [Not Specified]
5.Secondary Outcome
Title λz
Hide Description terminal rate constant of Telmisartan in plasma
Time Frame Serial pharmacokinetic blood samples collected before drug administration, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours after drug administration
Hide Outcome Measure Data
Hide Analysis Population Description
One subject who discontinued the study on period 2 was excluded from Pharmacokinetic data set. In analysis only used data which the parameter can be calculated.
Arm/Group Title T80/A5 mg FDC Tablet T80mg Tablet and A5 mg Tablet in Concomitant Use
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 110 112
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: /hour
0.0297
(52.5%)
0.0326
(45.1%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection T80/A5 mg FDC Tablet, T80mg Tablet and A5 mg Tablet in Concomitant Use
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Bioequivalence between T80/A 5mg FDC tablet and T80mg / A5 mg tablet in concomitant use
Statistical Test of Hypothesis P-Value [Not Specified]
Comments No statistical test
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Test/Reference Ratio of the mean x 100
Estimated Value 91.4
Confidence Interval 90%
85.6 to 97.6
Estimation Comments [Not Specified]
6.Secondary Outcome
Title t1/2
Hide Description terminal half-life of Telmisartan in plasma
Time Frame Serial pharmacokinetic blood samples collected before drug administration, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours after drug administration
Hide Outcome Measure Data
Hide Analysis Population Description
One subject who discontinued the study on period 2 was excluded from Pharmacokinetic data set. In analysis only used data which the parameter can be calculated.
Arm/Group Title T80/A5 mg FDC Tablet T80mg Tablet and A5 mg Tablet in Concomitant Use
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 110 112
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: hour
23.3
(52.5%)
21.3
(45.1%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection T80/A5 mg FDC Tablet, T80mg Tablet and A5 mg Tablet in Concomitant Use
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Bioequivalence between T80/A 5mg FDC tablet and T80mg / A5 mg tablet in concomitant use
Statistical Test of Hypothesis P-Value [Not Specified]
Comments No statistical test
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Test/Reference Ratio of the mean x 100
Estimated Value 109.4
Confidence Interval 90%
102.4 to 116.8
Estimation Comments [Not Specified]
7.Secondary Outcome
Title MRTpo
Hide Description mean residence time of Telmisartan in the body after oral administration
Time Frame Serial pharmacokinetic blood samples collected before drug administration, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours after drug administration
Hide Outcome Measure Data
Hide Analysis Population Description
One subject who discontinued the study on period 2 was excluded from Pharmacokinetic data set. In analysis only used data which the parameter can be calculated.
Arm/Group Title T80/A5 mg FDC Tablet T80mg Tablet and A5 mg Tablet in Concomitant Use
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 110 112
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: hour
21.8
(56.2%)
19.9
(50.5%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection T80/A5 mg FDC Tablet, T80mg Tablet and A5 mg Tablet in Concomitant Use
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Bioequivalence between T80/A 5mg FDC tablet and T80mg / A5 mg tablet in concomitant use
Statistical Test of Hypothesis P-Value [Not Specified]
Comments No statistical test
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Test/Reference Ratio of the mean x 100
Estimated Value 109.0
Confidence Interval 90%
101.5 to 117.1
Estimation Comments [Not Specified]
Time Frame From signing the informed consent onwards through the observational phase
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Treatment Sequence A Treatment Sequence B
Hide Arm/Group Description T80/A 5mg FDC tablet, Concomitant use, Concomitant use, T80/A 5mg FDC tablet Concomitant use, T80/A 5mg FDC tablet, T80/A 5mg FDC tablet, Concomitant use
All-Cause Mortality
Treatment Sequence A Treatment Sequence B
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Treatment Sequence A Treatment Sequence B
Affected / at Risk (%) Affected / at Risk (%)
Total   0/32 (0.00%)   0/32 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Treatment Sequence A Treatment Sequence B
Affected / at Risk (%) Affected / at Risk (%)
Total   0/32 (0.00%)   0/32 (0.00%) 
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
Layout table for Results Point of Contact information
Name/Title: Boehringer Ingelheim Call Center
Organization: Boehringer Ingelheim Pharmaceuticals
Phone: 1-800-243-0127
EMail: clintriage.rdg@boehringer-ingelheim.com
Layout table for additonal information
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01344629     History of Changes
Other Study ID Numbers: 1235.28
First Submitted: April 26, 2011
First Posted: April 29, 2011
Results First Submitted: July 10, 2012
Results First Posted: August 27, 2012
Last Update Posted: March 28, 2014