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Bioequivalence Study of Pediatric Formulations to Treat HIV Infection

NCT01469520 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2011-11-10

No results posted yet for this study

Summary

The purpose of the study is to determine the bioavailability/bioequivalence of two pediatric formulations (tablet and reconstitutable suspension) of lamivudine/zidovudine/ nevirapine in comparison to an innovator product. Establishing the bioequivalence of a newly developed age-appropriate fixed dose combination of lamivudine/zidovudine/ nevirapine as an oral dispersible tablet or a reconstitutable suspension for children is invaluable for future product registration and availability of the products to children, thus filling the void in pediatric HIV/AIDS therapy.

Conditions

Interventions

DRUG

Epivir®, Retrovir® and Viramune®

12 mL of Epivir® (lamivudine) 10 mg/mL solution plus 24 ml of Retrovir® (zidovudine) 10 mg/mL syrup plus and 20 mL of Viramune® (nevirapine) of 10 mg/mL

DRUG

Lamivudine, Zidovudine and nevirapine

20 mL of reconstituted granules for suspension containing lamivudine 30mg/zidovudine 60 mg/nevirapine 50 mg per 5 mL of suspension

DRUG

Lamivudine, zidovudine, nevirapine

Lamivudine 30mg/zidovudine 60 mg/nevirapine 50 mg per tablet.

Sponsors & Collaborators

  • Elim Pediatric Pharmaceuticals Inc.

    lead OTHER

Principal Investigators

  • Moji C Adeyeye, Ph.D · Elim Pediatric Pharmaceuticals Inc. and Roosevelt University

  • Daniel A Gbadero, MD · Bowen University Teaching Hospital, Ogbomoso, Nigeria

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
22 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-10-31
Primary Completion
2011-11-30
Completion
2011-12-31

Countries

  • Nigeria

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 NCT01469520 on ClinicalTrials.gov