A Study to Compare How Tamsulosin is Absorbed to the Body After Administration of Two Types of Tamsulosin Formulation Under Fed and Fasted Conditions in Chinese Healthy Subjects
NCT02138773 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 80
Last updated 2014-07-16
Summary
The purpose of this study is to investigate the relative bioavailability of two types of prolonged release formulation of tamsulosin hydrochloride in Chinese healthy subjects. The safety of tamsulosin formulation is also compared.
Conditions
- Healthy
- Pharmacokinetics of Tamsulosin Hydrochloride
Interventions
- DRUG
-
Tamsulosin formulation-A
oral
- DRUG
-
Tamsulosin formulation-B
oral
Sponsors & Collaborators
-
Astellas Pharma China, Inc.
lead INDUSTRY
Principal Investigators
-
Medical Director · Astellas Pharma Inc
Study Design
- Allocation
- RANDOMIZED
- Masking
- NONE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Max Age
- 40 Years
- Sex
- MALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2014-04-30
- Primary Completion
- 2014-07-31
- Completion
- 2014-07-31
Countries
- China
Study Locations
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