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Bioavailability Study of a New Pediatric Formulation of Zidovudine/Lamivudine in Adult Volunteers

Healthy Clinical Trial

Official title:
Bioavailability Study of a New Pediatric Formulation of Zidovudine/Lamivudine in Adult Volunteers

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00470041
Study type Interventional
Source University Ghent
Contact
Status Completed
Phase Phase 1
Start date June 2007
Completion date December 2009
View Details
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