drugset
drugset / Trial / NCT02183428

Bioavailability of BI 1356 and Glyburide in Healthy Male and Female Volunteers

NCT02183428 ↗

Phase 1 Completed 20 enrolled Boehringer Ingelheim
RandomizedCrossoverOpen-labelTreatment

Summary

The objective of this study was to investigate the effect of multiple doses BI 1356 given once daily in the estimated highest therapeutic dose of 5 mg until steady state on the pharmacokinetics, safety, and tolerability of a single oral conventional therapeutic dose of 1.75 mg glyburide. In addition, the effect of glyburide as a single oral dose of 1.75 mg being a conventional therapeutic dose on the multiple dose pharmacokinetics of BI 1356 was investigated. Pharmacokinetic profiles of glyburide were determined when given alone or in combination with BI 1356. Pharmacokinetic profiles of BI 1356 and its inactive metabolite CD 1750 were determined at steady state of BI 1356 when given alone or in combination with glyburide.

Timeline

Start
2008-05
Primary completion
2008-07
Completion
—

Drugs

EvaluationDrugModalityDoseRoute
Subject Glyburide Small molecule 1.75 mg Oral
Subject Linagliptin Small molecule 5 mg Oral

Indications

No indication recorded.