Bioavailability Study of a New Pediatric Formulation of Zidovudine/Lamivudine in Adult Volunteers
Status:
Completed
Trial end date:
2009-12-01
Target enrollment:
Participant gender:
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: 12 healthy volunteers will receive in a cross-over design two formulations
i.e. the commercially available tablet formulation and the trial formulation. Blood samples
(13 over 24 h) will be taken in order to determine the pharmacokinetic profile of the drugs
from both formulations and will be compared.
Duration of intervention: 2 days + 7 days of wash-out between both oral administrations.
Phase:
Phase 1
Details
Lead Sponsor:
University Ghent
Treatments:
Antiviral Agents Lamivudine Lamivudine, zidovudine drug combination Zidovudine