Status:
COMPLETED
Bioavailability Study of a New Pediatric Formulation of Zidovudine/Lamivudine in Adult Volunteers
Lead Sponsor:
University Ghent
Conditions:
Healthy
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
Description: To investigate bioavailability of two anti-viral drugs (lamivudine and zidovudine) from a new oral formulation (trial formulation) especially designed for pediatric use. Interventions: 1...
Eligibility Criteria
Inclusion
- Aged between 18 and 55 years, extremes included. Males and females.
- Smoking no more than 10 cigarettes, or 2 cigars, or 2 pipes per day (or non-smoking) for at least 3 months prior to selection.
- Normal weight as defined by a Quetelet Index (Body Mass Index) of 18 to 30 kg/m2, extremes included.
- Subject is competent and willing to sign informed consent form after being given all the detailed information about the study. Informed consent form signed voluntarily.
- Healthy on the basis of a pre-trial physical examination, medical history, electrocardiogram and the results of blood biochemistry and haematology tests and a urinalysis carried out less than 3 weeks before the first dose.
Exclusion
- Subjects presenting anaemia, neutropenia or platelets deficits
- Subjects with kidney failure or renal dysfunction
- Pregnant, lactating females
- History of allergy or hypersensitivity to Zidovudine or Lamivudine.
- History of clinically cardiovascular disease or liver disorder
Key Trial Info
Start Date :
June 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2009
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00470041
Start Date
June 1 2007
End Date
December 1 2009
Last Update
June 16 2010
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University Hospital Ghent
Ghent, Belgium, 9000