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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: BI 10773 (Final Formulation); Drug: BI 10773 XX (Trial Formulation 2)

• Registration Number: NCT01242176
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

The objective of the study is to investigate the relative bioavailability of the final tablet formulation (FF) of BI 10773 in comparison to the tablet formulation 2 (TF2).

Detailed Description

Not available

Study Timeline

• Study Start: 2010-11
• Study First Submitted: 2010-11-10
• Study First Submitted QC: 2010-11-15
• Study First Posted: 2010-11-16
• Primary Completion: 2010-12
• Status Verified: 2014-05
• Results First Submitted: 2014-05-16
• Results First Submitted QC: 2014-05-16
• Last Update Submitted: 2014-05-16
• Results First Posted: 2014-06-18
• Last Update Posted: 2014-06-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
BI 10773 Final Formulation	BI 10773 (Final Formulation)	one single film-coated tablet in the morning
BI 10773 XX Trial Formulation 2	BI 10773 XX (Trial Formulation 2)	one single dose tablet in the morning

Primary Outcome Measures

Name	Time	Method
Maximum Measured Concentration (Cmax)	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	Maximum measured concentration of empagliflozin (empa) in plasma.; Note the standard deviation is actually the CV (%).
Area Under the Curve 0 to Infinity (AUC0-∞)	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	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 (%)).

Secondary Outcome Measures

Name	Time	Method
Area Under the Curve 0 to the Last Quantifiable Data Point (AUC0-tz)	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	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 (%).

Trial Locations

Locations (1)

1245.51.1 Boehringer Ingelheim Investigational Site; 🇩🇪 Biberach, Germany