NCT01972880

A Study to Compare the Oral Absorption of ASP1941 Among Two Types of Tablets

ASP1941 Pharmacokinetic Study - Verification of Bioequivalence Between ASP1941 New Tablets and ASP1941 Conventional Tablets -

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Astellas Pharma Inc · Industry
• Sex: Male
• Age: 20 Years – 44 Years
• Healthy volunteers: Accepted

Summary

To assess the bioequivalence of a single dose of ASP1941 between tablet-1 and tablet-2 in a two-way crossover method in non-elderly healthy male subjects. In addition, the safety of these products will be assessed.

Detailed description

This study is a open-label randomized two-way crossover study. A single dose of two types of ASP1941 tablets are given to non-elderly healthy male subjects (16 subjects for each group, 32 subjects in total). In case the bioequivalence of the 2 formulations cannot be proved in this study due to insufficient number of subjects, an add-on subject study will be conducted in this clinical trial as needed. Same design and methodology are to be applied to this study and the add-on subject study. The add-on subject study may not be conducted.

Conditions

• Healthy
• Plasma Concentration of ASP1941

Interventions

Type	Name	Description
DRUG	ASP1941	Oral

Timeline

• Start date: 2013-09-01
• Primary completion: 2014-01-01
• Completion: 2014-01-01
• First posted: 2013-10-31
• Last updated: 2014-02-07

Locations

1 site across 1 country: Japan