Drug-interaction Trial in Healthy Subjects With Oral Administration of Empagliflozin (BI 10773), Rifampicin and Probenecid
Information source: Boehringer Ingelheim
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy
Intervention: Probenecid (Drug); Rifampicin (Drug); Empagliflozin (Drug); Empagliflozin (Drug); Rifampicin (Drug); Probenecid (Drug); Empagliflozin (BI 10773) (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Boehringer Ingelheim Official(s) and/or principal investigator(s): Boehringer Ingelheim, Study Chair, Affiliation: Boehringer Ingelheim
Summary
The objectives of the trial are to investigate the effect of concurrent administration of
rifampicin and probenecid on the pharmacokinetics of empagliflozin.
Clinical Details
Official title: A Randomised, Open-label, Three-way Crossover Trial to Investigate the Effect of Rifampicin and Probenecid on Empagliflozin Pharmacokinetics in Healthy Male and Female Subjects
Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Total Empagliflozin: Area Under the Curve 0 to Infinity (AUC0-∞)Total Empa: Maximum Measured Concentration (Cmax)
Secondary outcome: Total Empagliflozin: Area Under the Curve 0 to Time of Last Quantifiable Data Point (AUC0-tz)
Eligibility
Minimum age: 18 Years.
Maximum age: 50 Years.
Gender(s): Both.
Criteria:
Inclusion criteria:
1. healthy male and female subjects
Exclusion criteria:
1. any relevant deviation from healthy conditions
Locations and Contacts
1245.83.1 Boehringer Ingelheim Investigational Site, Biberach, Germany
Additional Information
Starting date: June 2012
Last updated: June 27, 2014
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