Bioequivalence Study of Pediatric Formulations to Treat HIV Infection

PHASE1UnknownINTERVENTIONAL
Enrollment

24

Participants

Timeline

Start Date

October 31, 2010

Primary Completion Date

November 30, 2011

Study Completion Date

December 31, 2011

Conditions
HIVAIDS
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.

Trial Locations (1)

234

Bowen University Teaching Hospital, Ogbomoso

All Listed Sponsors
lead

Elim Pediatric Pharmaceuticals Inc.

OTHER

NCT01469520 - Bioequivalence Study of Pediatric Formulations to Treat HIV Infection | Biotech Hunter | Biotech Hunter