drugset / Trial / NCT00767117

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

Phase 1 Completed 16 enrolled Tibotec Pharmaceuticals, Ireland
RandomizedCrossoverOpen-labelTreatment

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.

Timeline

Start
2008-09
Primary completion
2008-12
Completion
2008-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Etravirine Small molecule 200 mg
Subject Lopinavir Other / unclassified 400 mg
Subject Ritonavir Other / unclassified 100 mg