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

Sponsor
Boehringer Ingelheim
Study ID
NCT02782624
Phase
PHASE1
Status
Completed

Conditions

  • Healthy

Eligibility Criteria

Sex
ALL
Age
18 Years - 50 Years
Healthy Volunteers
Accepted

Interventions

  • Empagliflozin — DRUG
    5 days of treatment with 5 mg BI 10773 bid until steady state
  • Empagliflozin — DRUG
    5 days of treatment with 10 mg BI 10773 qd until steady state

Study Details

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

Key Dates

Start date
Sep 30, 2009
Status verified
May 2016
Primary completion
Nov 30, 2009
Completion
Nov 30, 2009

Study Design

Enrollment
16 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER

Arms

  • Experimental: Treatment A: Empagliflozin
    5 mg bid
  • Experimental: Treatment B: Empagliflozin
    10 mg qd

Primary Outcome Measure

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. [ Time Frame: up to 168 hours ]

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