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Trial record 24 of 3089 for:    Area Under Curve AND Healthy

Relative Bioavailability of Empagliflozin (BI 10773) (Final Formulation) Compared to Empagliflozin (BI 10773 XX) (Trial Formulation 2) in Healthy Male and Female Volunteers

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ClinicalTrials.gov Identifier: NCT01242176
Recruitment Status : Completed
First Posted : November 16, 2010
Results First Posted : June 18, 2014
Last Update Posted : June 18, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Healthy
Interventions Drug: BI 10773 XX (Trial Formulation 2)
Drug: BI 10773 (Final Formulation)
Enrollment 24
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Empa FF / Empa TF2 Empa TF2 / Empa FF
Hide Arm/Group Description Single dose of 25mg of empagliflozin (empa) final formulation (FF) followed by a single dose of 25mg empa trial formulation 2 (TF2), with a washout period of at least 7 days between treatments. Single dose of 25mg empagliflozin (empa) trial formulation 2 (TF2) followed by a single dose of 25mg of empa final formulation (FF), with a washout period of at least 7 days between treatments.
Period Title: First Intervention
Started 12 12
Completed 12 12
Not Completed 0 0
Period Title: Washout Period of 7 Days
Started 12 12
Completed 11 10
Not Completed 1 2
Reason Not Completed
Adverse Event             0             2
Non-compliant with protocol             1             0
Period Title: Second Intervention
Started 11 10
Completed 11 10
Not Completed 0 0
Arm/Group Title Study Overall
Hide Arm/Group Description

An open-label, randomised, two-way crossover study. The two treatments administered were

  • A single dose of empagliflozin (empa) 25mg, final formulation
  • A single dose of empa 25mg, trial formulation 2

Between drug administrations there was a washout period of at least 7 days.

Overall Number of Baseline Participants 24
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 24 participants
36.3  (9.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants
Female
10
  41.7%
Male
14
  58.3%
1.Primary Outcome
Title Area Under the Curve 0 to Infinity (AUC0-∞)
Hide Description

Area under the concentration-time curve of empagliflozin (empa) in plasma over the time interval from 0 extrapolated to infinity.

Note the standard deviation is actually the coefficient of variation (CV (%)).

Time Frame 30 minutes (mins) before drug administration and 20min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic (PK) set included all subjects who took at least one dose of study medication and who provided evaluable data for at least one observation for at least one primary PK endpoint without important protocol violations relevant to the evaluation of PK.
Arm/Group Title Empa FF Empa TF2
Hide Arm/Group Description:
Single dose of empagliflozin (empa) 25 mg, final formulation (FF), following an overnight fast of at least 10 hours.
Single dose of empagliflozin (empa) 25 mg, trial formulation 2 (TF2), following an overnight fast of at least 10 hours.
Overall Number of Participants Analyzed 21 23
Mean (Standard Deviation)
Unit of Measure: nmol*h/L
5200  (20.7) 5090  (17.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Empa FF, Empa TF2
Comments Ratio calculated as empa final formulation divided by empa trial formulation 2
Type of Statistical Test Non-Inferiority or Equivalence
Comments No formal testing, investigation of relative bioavailability
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments Based on ANOVA with terms for sequence, subjects within sequence, period and treatment.
Method of Estimation Estimation Parameter Geometric Mean Ratio
Estimated Value 101.67
Confidence Interval (2-Sided) 90%
98.10 to 105.37
Parameter Dispersion
Type: Standard Deviation
Value: 6.7
Estimation Comments Standard deviation is actually the geometric coefficient of variation (gCV).
2.Primary Outcome
Title Maximum Measured Concentration (Cmax)
Hide Description

Maximum measured concentration of empagliflozin (empa) in plasma.

Note the standard deviation is actually the CV (%).

Time Frame 30 minutes (mins) before drug administration and 20min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic (PK) set included all subjects who took at least one dose of study medication and who provided evaluable data for at least one observation for at least one primary PK endpoint without important protocol violations relevant to the evaluation of PK.
Arm/Group Title Empa FF Empa TF2
Hide Arm/Group Description:
Single dose of empagliflozin (empa) 25 mg, final formulation (FF), following an overnight fast of at least 10 hours.
Single dose of empagliflozin (empa) 25 mg, trial formulation 2 (TF2), following an overnight fast of at least 10 hours.
Overall Number of Participants Analyzed 21 23
Mean (Standard Deviation)
Unit of Measure: nmol/L
764  (26.5) 764  (23.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Empa FF, Empa TF2
Comments Ratio calculated as empa final formulation divided by empa trial formulation 2
Type of Statistical Test Non-Inferiority or Equivalence
Comments No formal testing, investigation of relative bioavailability
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments Based on ANOVA with terms for sequence, subjects within sequence, period and treatment.
Method of Estimation Estimation Parameter Geometric Mean Ratio
Estimated Value 99.46
Confidence Interval (2-Sided) 90%
90.18 to 109.68
Parameter Dispersion
Type: Standard Deviation
Value: 18.7
Estimation Comments Standard deviation is actually the gCV.
3.Secondary Outcome
Title Area Under the Curve 0 to the Last Quantifiable Data Point (AUC0-tz)
Hide Description

Area under the concentration-time curve of empagliflozin (empa) in plasma over the time interval from 0 to the time of the last quantifiable data point.

Note the standard deviation is actually the CV (%).

Time Frame 30 minutes (mins) before drug administration and 20min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h after drug administration
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic (PK) set included all subjects who took at least one dose of study medication and who provided evaluable data for at least one observation for at least one primary PK endpoint without important protocol violations relevant to the evaluation of PK.
Arm/Group Title Empa FF Empa TF2
Hide Arm/Group Description:
Single dose of empagliflozin (empa) 25 mg, final formulation (FF), following an overnight fast of at least 10 hours.
Single dose of empagliflozin (empa) 25 mg, trial formulation 2 (TF2), following an overnight fast of at least 10 hours.
Overall Number of Participants Analyzed 21 23
Mean (Standard Deviation)
Unit of Measure: nmol*h/L
5140  (20.8) 5030  (18.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Empa FF, Empa TF2
Comments Ratio calculated as empa final formulation divided by empa trial formulation 2
Type of Statistical Test Non-Inferiority or Equivalence
Comments No formal testing, investigation of relative bioavailability
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments Based on ANOVA with terms for sequence, subjects within sequence, period and treatment.
Method of Estimation Estimation Parameter Geometric Mean Ratio
Estimated Value 101.80
Confidence Interval (2-Sided) 90%
98.26 to 105.48
Parameter Dispersion
Type: Standard Deviation
Value: 6.7
Estimation Comments Standard deviation is actually the gCV.
Time Frame From drug administration until end of study visit, up to 10 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Empa FF Empa TF2
Hide Arm/Group Description Single dose of empagliflozin (empa) 25 mg, final formulation (FF), following an overnight fast of at least 10 hours. Single dose of empagliflozin (empa) 25 mg, trial formulation 2 (TF2), following an overnight fast of at least 10 hours.
All-Cause Mortality
Empa FF Empa TF2
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Empa FF Empa TF2
Affected / at Risk (%) Affected / at Risk (%)
Total   0/22 (0.00%)   1/23 (4.35%) 
Nervous system disorders     
Migraine with aura  1  0/22 (0.00%)  1/23 (4.35%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MEDDRA 13.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Empa FF Empa TF2
Affected / at Risk (%) Affected / at Risk (%)
Total   1/22 (4.55%)   4/23 (17.39%) 
Nervous system disorders     
Headache  1  1/22 (4.55%)  4/23 (17.39%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MEDDRA 13.1
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Boehringer Ingelheim Call Center
Organization: Boehringer Ingelheim Pharmaceuticals
Phone: 1-800-243-0127
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01242176     History of Changes
Other Study ID Numbers: 1245.51
2010-022469-81 ( EudraCT Number: EudraCT )
First Submitted: November 10, 2010
First Posted: November 16, 2010
Results First Submitted: May 16, 2014
Results First Posted: June 18, 2014
Last Update Posted: June 18, 2014