Drug-interaction Trial in Healthy Subjects With Oral Administration of Empagliflozin (BI 10773), Rifampicin and Probenecid

Sponsor
Boehringer Ingelheim
Study ID
NCT01634100
Phase
PHASE1
Status
Completed

Conditions

  • Healthy

Eligibility Criteria

Sex
ALL
Age
18 Years - 50 Years
Healthy Volunteers
Accepted

Interventions

Study Details

The objectives of the trial are to investigate the effect of concurrent administration of rifampicin and probenecid on the pharmacokinetics of empagliflozin.

Key Dates

Start date
Jun 30, 2012
Status verified
Jun 2014
Primary completion
Aug 31, 2012
Completion
Aug 31, 2012

Study Design

Enrollment
18 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: A (Reference)
    Empagliflozin (BI 10773), Film-coated tablet, single dose
  • Experimental: B (Test 1)
    Empagliflozin (BI 10773), Film-coated tablet, single dose, and Rifampicin,Film-coated tablet single dose
  • Experimental: C (Test 2)
    Empagliflozin (BI 10773), Film-coated tablet, single dose, and Probenecid Tablet twice daily

Primary Outcome Measure

Total Empagliflozin: Area Under the Curve 0 to Infinity (AUC0-∞) [ Time Frame: 15 minutes (min) prior to the first dose and 20min, 40min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h and 72h after the first dose ]

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