drugset / Trial / NCT02194179

Bioavailability of 2 Different Nevirapine Extended Release Formulations Compared to Viramune® in HIV-1 Infected Subjects

NCT02194179

Phase 1 Completed 92 enrolled Boehringer Ingelheim
Non-randomizedParallel-groupOpen-labelTreatment

Summary

The objective was to establish the pharmacokinetic (PK) profile at steady state of two different nevirapine (NVP) extended release (XR) formulations at 300 mg or 400 mg daily (QD) under fasted and fed conditions in comparison with the commercially available NVP immediate release (IR) tablet at 200 mg BID (400 mg/day).

Timeline

Start
2006-12
Primary completion
2007-05
Completion

Drugs

EvaluationDrugModalityDoseRoute
Subject Nevirapine Small molecule 200 mg
Subject Nevirapine Small molecule 300 mg
Subject Nevirapine Small molecule 400 mg