Bioequivalence Study of Pediatric Formulations to Treat HIV Infection

• Status: Unknown status
• Trial end date: 2011-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Elim Pediatric Pharmaceuticals Inc.
• Treatments: Lamivudine; Nevirapine; Zidovudine

Criteria

Inclusion Criteria:

• The eligibility criteria included adults between 22 and 55 years;

• Healthy as determined on the basis of a pre-trial physical examination, medical history, electrocardiogram and the results of blood biochemistry and hematology tests;

• Subject was competent and willing to sign informed consent form voluntarily after being given all the detailed information about the study;

• Willing to be hospitalized for the 24-hour intensive sampling period.

Exclusion Criteria:

• The exclusion criteria was hypersensitivity to study drugs;

• Abnormal laboratory biochemistry values;

• Smokers;

• Any clinically significant diseases or findings during the screening, medical history or physical examination that, in the opinion of the investigator, may interfere with the study;

• Treatment with experimental drugs within 30 days prior to study entry.