A Randomized, Open Label, Single Dose, 2-Way Cross-over Clinical Trial to Compare the Safety and Pharmacokinetic Characteristics of Exforge® and G-0081 in Healthy Male Volunteers
NCT01776047 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 51
Last updated 2013-01-25
Summary
Study Design : randomized, open label, single-dose, 2-way cross-over design
Phase : Phase I
Conditions
- Healthy Male Volunteer
Interventions
- DRUG
-
Exforge®
- DRUG
-
G-0081
Sponsors & Collaborators
-
Dong-A Pharmaceutical Co., Ltd.
lead INDUSTRY
Principal Investigators
-
K S Park, MD, PhD · Head of Clinical Development, Clinical Trials Center Severance Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- CROSSOVER
Eligibility
- Min Age
- 20 Years
- Max Age
- 50 Years
- Sex
- MALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2012-07-31
- Primary Completion
- 2012-09-30
- Completion
- 2012-09-30
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