Bioequivalence Study of Tacrobell Capsule 1mg to Prograf Capsule 1mg
NCT01910077 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50
Last updated 2014-07-23
Summary
The purpose of this study is to demonstrate bioequivalence between tacrobell capsule 1mg and prograf capsule 1mg.
Conditions
- Immunosuppression
Interventions
- DRUG
-
Tacrobell capsule 1mg
1 capsule, oral, over the period I\&II(crossover)
- DRUG
-
Prograf capsule 1mg
1 capsule, oral, over the period I\&II(crossover)
Sponsors & Collaborators
-
Chong Kun Dang Pharmaceutical
lead INDUSTRY
Principal Investigators
-
Hyeong Ki Lee, MD, Ph.D · Seoul National University Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- CROSSOVER
Eligibility
- Min Age
- 19 Years
- Max Age
- 55 Years
- Sex
- MALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2013-08-31
- Primary Completion
- 2013-08-31
- Completion
- 2013-11-30
Countries
- South Korea
Study Locations
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