Study to Assess the Safety and Plasma Concentration of YM178 OCAS Tablet (Mirabegron) in Healthy Chinese Volunteers

Astellas

Status and phase: Completed; Phase 1

Conditions: Healthy Chinese Volunteers

Treatments: Drug: YM178

Study type: Interventional

Funder types: Industry

Identifiers

NCT01720212

178-CL-091

Details and patient eligibility

About

To evaluate the safety and plasma concentration change of YM178 after single- and repeated-administration as oral absorption controlled tablet in healthy Chinese subjects.

Enrollment: 24 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Body Mass Index (BMI) between 19 and 24, the weight is no less than 50 kg.
2. Good health status
3. The female subject must be either post-menopausal or surgically sterile. All women of child bearing potential will be required to use adequate contraception, must not be lactating, and must not be breastfeeding.

Exclusion criteria

1. The subject who has a known or suspected hypersensitivity to test drug or any of the constituents of the formulation used.
2. Drug abusers and alcoholics.
3. The subject who has consumed alcohol within 36 hours before administration.
4. The subject who is positive for hepatitis B surface antigen (HBs- Ag) or hepatitis C virus (HCV) antibody.
5. The subject who is positive for human immunodeficiency virus (HIV).
6. The subject who consumes more than 1L tea and coffee per day.
7. Smokers.
8. The subject who has donated or lost over 200 mL blood
9. The subject who has participated in other clinical trials
10. The subject who has taken other drugs that prototype and its main metabolites had not completely eliminated
11. The subject who has taken drugs repeatedly that may affect the metabolism of the test drug
12. Psychopath.

Trial design

24 participants in 2 patient groups

Single dose group

Experimental group

Treatment:

Drug: YM178

Multiple dose group

Experimental group

Treatment:

Drug: YM178