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Multiple Dose BE Study With Nevirapine 400mg PR Tablets

NCT02202005 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2015-08-25

No results posted yet for this study

Summary

The objective of this steady state pivotal study is to compare the rate and extent of absorption and to evaluate Bioequivalence of test drug compared to the approved reference product in HIV infected individuals

Conditions

Interventions

DRUG

Nevirapine

Nevirapine 400mg PR tablet

DRUG

Viramune®

Viramune® 400 mg Retardtabletten

Sponsors & Collaborators

  • Ratiopharm GmbH

    lead INDUSTRY

Principal Investigators

  • Teva Medical Expert, MD · Chelsea and Westminster NHS Foundation Trust

Study Design

Allocation
NON_RANDOMIZED
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2014-08-31
Primary Completion
2015-07-31
Completion
2015-08-31

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

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 NCT02202005 on ClinicalTrials.gov