Drug-drug Interaction Study With ASP1941 and Glimepiride

Astellas

Status and phase

Completed

Phase 1

Conditions

Healthy Subjects

Treatments

Drug: ASP1941

Drug: Glimepiride

Study type

Interventional

Funder types

Industry

Identifiers

NCT01302158

1941-CL-0059

2009-013172-50 (EudraCT Number)

Details and patient eligibility

About

A study to investigate the effect of ASP1941 on the pharmacokinetics and safety of glimepiride (Part A) and to investigate the effect of glimepiride on the pharmacokinetics, safety and pharmacodynamics of ASP1941 (Part B).

Full description

Study includes two parts. Part A is to investigate the effect of multiple oral doses of ASP1941 on the pharmacokinetics of glimepiride, and Part B is to investigate the effect of multiple oral doses of glimepiride on the pharmacokinetics of ASP1941.

Enrollment

52 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

BMI between 18.5 and 30 kg/m2, inclusive

Exclusion criteria

Any of the liver function tests above the upper limit of normal
Pulse <40 or >90 bpm; Systolic Blood Pressure >140 mmHg; Diastolic Blood Pressure > 90 mmHg