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Pharmacokinetic Properties of Two Dosages Nevirapine Extended Release (XR) Formulations Compared to VIRAMUNE® Tablet as Well as to Nevirapine XR Tablet in Healthy Male Volunteers

NCT02184312 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2014-07-14

No results posted yet for this study

Summary

Study to determine the pharmacokinetic properties of 200 mg (2 x 100 mg tablets once daily) and 300 mg (3 x 100 mg tablets once daily) Nevirapine extended release formulations and to estimate relative bioavailability of these formulations as compared to 200 mg VIRAMUNE® tablet as well as to 400 mg Nevirapine extended release tablet

Conditions

  • Healthy

Interventions

DRUG

Nevirapine XR low dose

DRUG

Nevirapine XR medium dose

DRUG

Nevirapine XR high dose

DRUG

Nevirapine (VIRAMUNE®)

Sponsors & Collaborators

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-04-30
Primary Completion
2008-07-31

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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 NCT02184312 on ClinicalTrials.gov