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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

Page last updated: August 23, 2015

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