Bioequivalence Study of Pediatric Formulations to Treat HIV Infection
Status:
Unknown status
Trial end date:
2011-12-01
Target enrollment:
Participant gender:
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.