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

Phase 1

Completed

• Conditions: Healthy Volunteers; Pharmacokinetics of ASP1941
• Interventions: Drug: ASP1941; Drug: Miglitol

• Registration Number: NCT01099839
• Lead Sponsor: 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".

Study Timeline

• Study Start: 2010-02
• Study First Submitted: 2010-03-30
• Primary Completion: 2010-04
• Study Completion: 2010-04
• Study First Submitted QC: 2010-04-06
• Study First Posted: 2010-04-08
• Status Verified: 2010-06
• Last Update Submitted: 2010-06-08
• Last Update Posted: 2010-06-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
one group	ASP1941	Subjects will receive "ASP1941 alone", "Miglitol alone" and "ASP1941 + Miglitol" in different order.
one group	Miglitol	Subjects will receive "ASP1941 alone", "Miglitol alone" and "ASP1941 + Miglitol" in different order.

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics of ASP1941 and Miglitol through analysis of blood samples	For 72 hours after each administration