Relative Bioavailability of Single Dose Empagliflozin (BI 10773) When Co-administered With Multiple Doses of 600 mg Gemfibrozil Compared to Single Dose Treatment With Empagliflozin (BI 10773) When Given Alone in Healthy Volunteers

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: BI 10773; Drug: Gemfibrozil

• Registration Number: NCT01301742
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

To investigate the relative bioavailability of BI 10773 following coadministration with 600 mg gemfibrozil bid dosed to steady-state in comparison to BI 10773 when given alone.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-02
• Study First Submitted: 2011-02-22
• Study First Submitted QC: 2011-02-22
• Study First Posted: 2011-02-23
• Primary Completion: 2011-05
• 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: 18

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
BI 10773	BI 10773	Subject to receive one single dose BI 10773
BI 10773	Gemfibrozil	Subject to receive one single dose BI 10773
BI 10773 plus gemfibrozil	BI 10773	Subject to receive one single dose BI 10773 plus 600 mg gemfibrozil bid for 5 days

Primary Outcome Measures

Name	Time	Method
Total Empa: Area Under the Curve 0 to Infinity (AUC0-∞)	0 minutes (min), 20 min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 23h, 36h, 47h, 71h after the first dose	Area under the plasma concentration-time curve of the analyte from time 0 extrapolated to infinity.; The standard deviation presented in the analysis is actually the intra-individual geometric standard deviation (gCV).
Total Empa: Maximum Measured Concentration (Cmax)	0 minutes (min), 20min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 23h, 36h, 47h, 71h after the first dose	Maximum measured concentration of total Empagliflozin (Empa) in plasma, per period.; The standard deviation presented in the analysis is actually the intra-individual geometric standard deviation (gCV).

Secondary Outcome Measures

Name	Time	Method
Total Empa: Area Under the Curve 0 to Time of Last Quantifiable Data Point (AUC0-tz)	0 minutes (min), 20 min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 23h, 36h, 47h, 71h after the first dose	Area under the plasma concentration-time curve of the analyte from time 0 to the time of the last quantifiable data point.; The standard deviation presented in the analyses is actually the intra-individual geometric standard deviation (gCV).

Trial Locations

Locations (1)

1245.58.1 Boehringer Ingelheim Investigational Site; 🇩🇪 Biberach, Germany