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

Healthy Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01099839
• Other study ID #: 1941-CL-0062
• Status: Completed
• Phase: Phase 1
• First received: March 30, 2010
• Last updated: June 8, 2010
• Start date: February 2010
• Est. completion date: April 2010

Study information

• Verified date: June 2010
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial Summary

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

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".

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: April 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 44 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Healthy Volunteers
• Pharmacokinetics of ASP1941

Intervention

Drug:
• ASP1941
oral
• Miglitol
oral

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Inc

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics of ASP1941 and Miglitol through analysis of blood samples		For 72 hours after each administration	No