Study to Assess the Safety and Plasma Concentration of YM178 OCAS Tablet (Mirabegron) in Healthy Chinese Volunteers
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ClinicalTrials.gov Identifier: NCT01720212
: November 2, 2012
Last Update Posted
: November 2, 2012
Astellas Pharma China, Inc.
Information provided by (Responsible Party):
Astellas Pharma Inc ( Astellas Pharma China, Inc. )
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Ages Eligible for Study:
18 Years to 40 Years (Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Body Mass Index (BMI) between 19 and 24, the weight is no less than 50 kg.
Good health status
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.
The subject who has a known or suspected hypersensitivity to test drug or any of the constituents of the formulation used.
Drug abusers and alcoholics.
The subject who has consumed alcohol within 36 hours before administration.
The subject who is positive for hepatitis B surface antigen (HBs- Ag) or hepatitis C virus (HCV) antibody.
The subject who is positive for human immunodeficiency virus (HIV).
The subject who consumes more than 1L tea and coffee per day.
The subject who has donated or lost over 200 mL blood
The subject who has participated in other clinical trials
The subject who has taken other drugs that prototype and its main metabolites had not completely eliminated
The subject who has taken drugs repeatedly that may affect the metabolism of the test drug