NCT01302158

Drug-drug Interaction Study With ASP1941 and Glimepiride

An Open-label, Randomized Crossover Study to Evaluate the Effect of ASP1941 on the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Glimepiride in Healthy Subjects and Vice Versa

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: Astellas Pharma Inc · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

A study to investigate the effect of ASP1941 on the pharmacokinetics and safety of glimepiride (Part A) and to investigate the effect of glimepiride on the pharmacokinetics, safety and pharmacodynamics of ASP1941 (Part B).

Detailed description

Study includes two parts. Part A is to investigate the effect of multiple oral doses of ASP1941 on the pharmacokinetics of glimepiride, and Part B is to investigate the effect of multiple oral doses of glimepiride on the pharmacokinetics of ASP1941.

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
DRUG	ASP1941	oral
DRUG	Glimepiride	oral

Timeline

• Start date: 2009-12-01
• Primary completion: 2010-04-01
• Completion: 2010-04-01
• First posted: 2011-02-23
• Last updated: 2011-02-23

Locations

1 site across 1 country: Netherlands