Status:
UNKNOWN
Bioequivalence Study of Pediatric Formulations to Treat HIV Infection
Lead Sponsor:
Elim Pediatric Pharmaceuticals Inc.
Conditions:
HIV
AIDS
Eligibility:
All Genders
22-55 years
Phase:
PHASE1
Brief 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 ...
Detailed Description
Volunteer Selection and Size: The International Conference on Harmonization (ICH) guideline E11 on clinical investigation of medicinal products in the pediatric population suggests that for relative b...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT01469520
Start Date
October 1 2010
End Date
December 1 2011
Last Update
November 10 2011
Active Locations (1)
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1
Bowen University Teaching Hospital
Ogbomoso, Oyo State, Nigeria, 234