TMC435-TiDP16-C121: A Study Comparing 2 Tablet Formulations of TMC435 to an Established Capsule Formulation and Evaluating the Effect of Food on Blood Levels of TMC435
NCT01022125 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 28
Last updated 2010-05-17
Summary
The purpose of this study is to compare the levels of TMC435 in the blood circulation after intake of 2 tablet formulations with the level of TMC435 in the blood circulation after intake of a capsule formulation. The trial will also evaluate levels of TMC435 in the blood circulation after intake of the capsule formulation fasted or following a meal.
Conditions
- Hepatitis C Virus
Interventions
- DRUG
-
TMC435
Sponsors & Collaborators
-
Tibotec Pharmaceuticals, Ireland
lead INDUSTRY
Principal Investigators
-
Tibotec Pharmaceuticals Clinical Trial · Tibotec Pharmaceutical Limited
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Max Age
- 55 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2010-01-31
- Primary Completion
- 2010-04-30
- Completion
- 2010-04-30
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