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Relative Bioavailability of Different Oral Viramune Extended Release Formulations Compared to Viramune® Oral Suspension in Healthy Male Volunteers

NCT02192463 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 204

Last updated 2014-07-16

No results posted yet for this study

Summary

Study to determine the relative bioavailability of different oral Viramune Extended Release (ER) formulations compared to Viramune® Immediate Release (IR) tablet

Conditions

  • Healthy

Interventions

DRUG

NVP ER 300 mg (KCR 20%) Medium Release

DRUG

NVP ER 300 mg (KCR 25%) Medium Release

DRUG

NVP ER 300 mg (KCR 30%) Slow Release

DRUG

NVP ER 400 mg (KCR 25%) Medium Release

DRUG

NVP ER 300 mg (KCR 40%) Slow Release

DRUG

NVP ER 300 mg (ECR 20%) Fast Release

DRUG

NVP ER 400 mg (KCR 20%) Medium Release

DRUG

NVP ER 400 mg (KCR 30%) Slow Release

DRUG

NVP ER 400 mg (KCR 40%) Slow Release

DRUG

NVP ER 400 mg (ECR 20%) Fast Release

DRUG

Nevirapine immediate release (IR) 200 mg

Sponsors & Collaborators

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2006-04-30
Primary Completion
2006-08-31

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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 NCT02192463 on ClinicalTrials.gov