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

Astellas

Status and phase: Completed; Phase 1

Conditions: Pharmacokinetics of ASP1941; Healthy Volunteers

Treatments: Drug: ASP1941; Drug: Miglitol

Study type: Interventional

Funder types: Industry

Identifiers

NCT01099839

1941-CL-0062

Details and patient eligibility

About

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

Full 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".

Enrollment: 30 patients

Sex: Male

Ages: 20 to 44 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

30 participants in 1 patient group

one group

Experimental group

Description:

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

Treatment:

Drug: Miglitol

Drug: ASP1941