A Study to Assess Drug-Drug Interaction Between ASP1941 and Miglitol

A Phase I Study to Assess Drug-Drug Interaction Between ASP1941 and Miglitol.

Sponsors

Lead Sponsor: Astellas Pharma Inc

Source Astellas Pharma Inc
Brief Summary

This study is to assess the pharmacokinetic interaction between ASP1941 and Miglitol in healthy volunteers.

Detailed Description

This will be a randomized, open-label, 3-way crossover design study to assess the drug-drug interaction between a single oral dose of ASP1941 and a single oral dose of Miglitol in healthy adult male volunteers. Each subject will receive "ASP1941 alone", "Miglitol alone" and "ASP1941 + Miglitol".

Overall Status Completed
Start Date 2010-02-01
Completion Date 2010-04-01
Primary Completion Date 2010-04-01
Phase Phase 1
Study Type Interventional
Primary Outcome
Measure Time Frame
Pharmacokinetics of ASP1941 and Miglitol through analysis of blood samples For 72 hours after each administration
Enrollment 30
Condition
Intervention

Intervention Type: Drug

Intervention Name: ASP1941

Description: oral

Arm Group Label: one group

Intervention Type: Drug

Intervention Name: Miglitol

Description: oral

Arm Group Label: one group

Other Name: Seibule

Eligibility

Criteria:

Inclusion Criteria: - Healthy as judged by the investigator/subinvestigator based on the results of physical examinations and laboratory tests - Body weight ; ≥50.0 kg, <80.0 kg - Body Mass Index ; ≥17.6, <26.4 - Written informed consent has been obtained Exclusion Criteria: - Received any investigational drugs within 120 days before the screening assessment - Donated 400 mL of whole blood within 90 days, 200 mL of whole blood within 30 days, or blood components within 14 days before the screening assessment - Received medication within 7 days before hospital admission - A deviation from the assessment criteria of physical examinations or laboratory tests at screening or upon admission - History of drug allergies - With renal, hepatic, gastrointestinal, heart, cerebrovascular or respiratory diseases - Previous treatment with ASP1941

Gender:

Male

Minimum Age:

20 Years

Maximum Age:

44 Years

Healthy Volunteers:

Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Use Central Contact Study Chair Astellas Pharma Inc
Location
Facility:
Location Countries

Japan

Verification Date

2010-06-01

Responsible Party

Name Title: Director

Organization: Astellas Pharma, Inc

Keywords
Has Expanded Access No
Number Of Arms 1
Arm Group

Label: one group

Type: Experimental

Description: Subjects will receive "ASP1941 alone", "Miglitol alone" and "ASP1941 + Miglitol" in different order.

Study Design Info

Allocation: Randomized

Intervention Model: Crossover Assignment

Masking: None (Open Label)

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