NCT01104532

A Study to Characterize the Effect on the Pharmacokinetics of ASP1941 and Sitagliptin When Given Together to Healthy Subjects

A Phase 1, Open Label, Randomized, Crossover, Drug Interaction Study of the Pharmacokinetics of ASP1941 and Sitagliptin After Separate and Concomitant Administration to Healthy Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: Astellas Pharma Inc · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of the study is to evaluate pharmacokinetics, pharmacodynamics and safety following the administration of ASP1941 and sitagliptin in single and multiple doses.

Detailed description

All subjects will be enrolled at one center and confined to the unit for up to 17 days. Subjects will be dosed in the fasting state in one of the four groups.

Conditions

• Healthy
• Pharmacokinetics of ASP1941

Interventions

Type	Name	Description
DRUG	ASP1941	oral tablet
DRUG	sitagliptin	oral tablet

Timeline

• Start date: 2010-02-01
• Primary completion: 2010-03-01
• Completion: 2010-03-01
• First posted: 2010-04-15
• Last updated: 2010-04-16

Locations

1 site across 1 country: United States