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

NCT02194179 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 92

Last updated 2014-07-18

No results posted yet for this study

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).

Conditions

  • HIV Infections

Interventions

DRUG

NVP XR 400 mg (KCR 25%)

DRUG

NVP XR 400 mg (KCR 20%)

DRUG

NVP XR 300 mg (KCR 25%)

DRUG

NVP XR 300 mg (KCR 20%)

OTHER

high-fat breakfast

DRUG

NVP IR 200 mg (Viramune®)

Sponsors & Collaborators

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-12-31
Primary Completion
2007-05-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02194179 on ClinicalTrials.gov