A Study to Assess the Effect of ASP1941 and Mitiglinide on Their Plasma Concentration

Astellas

Status and phase

Completed

Phase 1

Conditions

Pharmacokinetics of ASP1941

Healthy

Pharmacokinetics of Mitiglinide

Treatments

Drug: Mitiglinide calcium hydrate

Drug: ASP1941

Study type

Interventional

Funder types

Industry

Identifiers

NCT01403818

1941-CL-0074

Details and patient eligibility

About

This study is to assess the pharmacokinetic interaction between ASP1941 and Mitiglinide calcium hydrate in healthy volunteers.

Full description

This will be a randomized, open label, four group, two-way crossover design study to assess the effect of drug interaction between ASP1941 and Mitiglinide calcium hydrate on the pharmacokinetics of them after separate and concomitant administration to healthy non-elderly adult male subjects.

Enrollment

60 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 kg/m2
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 d 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