TMC125-TiDP2-C197: A Phase I Trial to Investigate the Pharmacokinetic Interaction Between Lopinavir/Ritonavir and TMC125 Both at Steady-state in Healthy Volunteers.
NCT00767117 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16
Last updated 2011-06-09
Summary
The purpose of the study is to determine the effect of steady-state concentrations of LPV, co-administered with a low dose of ritonavir, on the steady-state pharmacokinetics of TMC125 and to determine the effect of steady-state concentrations of TMC125 on the steady-state pharmacokinetics of LPV, co-administered with a low dose of ritonavir.
Conditions
Interventions
- DRUG
-
Etravirine; Lopinavir; Ritonavir
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
- 2008-09-30
- Primary Completion
- 2008-12-31
- Completion
- 2008-12-31
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