NCT00470041

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: University Ghent · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	administration of two anti-viral drugs (lamivudine and zidovudine) from a new oral formulation

Timeline

• Start date: 2007-06-01
• Primary completion: 2009-10-01
• Completion: 2009-12-01
• First posted: 2007-05-07
• Last updated: 2010-06-16

Locations

1 site across 1 country: Belgium