Relative Bioavailability of BI 10773 Administered Twice Daily Compared BI 10773 Given Once Daily After Multiple Oral Doses in Healthy Male and Female Volunteers

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Empagliflozin

• Registration Number: NCT02782624
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

To investigate the influence of different dosage regimen (5 mg twice daily versus 10 mg once daily) on the steady state pharmacokinetics and pharmacodynamics of BI 10773 administered orally

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09
• Primary Completion: 2009-11
• Study Completion: 2009-11
• Status Verified: 2016-05
• Study First Submitted: 2016-05-23
• Study First Submitted QC: 2016-05-23
• Last Update Submitted: 2016-05-23
• Study First Posted: 2016-05-25
• Last Update Posted: 2016-05-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Treatment A: Empagliflozin	Empagliflozin	5 mg bid
Treatment B: Empagliflozin	Empagliflozin	10 mg qd

Primary Outcome Measures

Name	Time	Method
Cmax,ss (maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval t) of BI 10773.	up to 168 hours
AUC (area under the concentration-time curve of the analyte in plasma) - AUCt,ss (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval t) for 10 mg BI 10773 QD.	up to 168 hours
AUC (area under the concentration-time curve of the analyte in plasma) - AUC0-24,ss (area under the concentration-time curves of the analyte in plasma at steady-state over two dosing intervals) for 5 mg BI 10773 BID after the morning dose on Day 5.	up to 168 hours
AUCt,ss (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval t) of BI 10773.	up to 168 hours

Secondary Outcome Measures

Name	Time	Method
tmax,ss (time from last dosing to maximum concentration of the analyte in plasma at steady state over a uniform dosing interval t) of BI 10773.	up to 168 hours
Cavg (average concentration of the analyte in plasma at steady state) of BI 10773	up to 168 hours
¿z,ss (terminal half-life of the analyte in plasma at steady state) of BI 10773	up to 168 hours
C12,N (concentration of analyte in plasma at 12 hours post-drug administration after administration of the Nth dose for the BID regimen) of BI 10773.	up to 168 hours
CL/F,ss (apparent clearance of the analyte in the plasma after extravascular administration at steady state) of BI 10773.	up to 168 hours
PTF (percentage peak-trough fluctuation)	up to 168 hours
C24,N (concentration of analyte in plasma at 24 hours post-drug administration after administration of the Nth dose for the QD regimen) of BI 10773.	up to 168 hours
Cmin,ss (minimum measured concentration of the analyte in plasma at steady state over a uniform dosing interval t) of BI 10773	up to 168 hours
MRTpo,ss (mean residence time of the analyte in the body at steady state after oral administration) of BI 10773.	up to 168 hours
Vz/F,ss (apparent volume of distribution during the terminal phase tau z at steady state following extravascular administration) of BI 10773.	up to 168 hours
t½,ss (terminal half-life of the analyte in plasma at steady state) of BI 10773	up to 168 hours

Trial Locations

Locations (1)

1276.9.1 Boehringer Ingelheim Investigational Site; 🇩🇪 Biberach, Germany