Bioavailability Study of a New Pediatric Formulation of Zidovudine/Lamivudine in Adult Volunteers
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|ClinicalTrials.gov Identifier: NCT00470041|
Recruitment Status : Completed
First Posted : May 7, 2007
Last Update Posted : June 16, 2010
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.
|Condition or disease||Intervention/treatment||Phase|
|Healthy||Drug: administration of two anti-viral drugs (lamivudine and zidovudine) from a new oral formulation||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Bioavailability Study of a New Pediatric Formulation of Zidovudine/Lamivudine in Adult Volunteers|
|Study Start Date :||June 2007|
|Actual Primary Completion Date :||October 2009|
|Actual Study Completion Date :||December 2009|
- bioavailability of two anti-viral drugs (lamivudine and zidovudine) from a new oral formulation (trial formulation) especially designed for pediatric use [ Time Frame: over 24 hours ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00470041
|University Hospital Ghent|
|Ghent, Belgium, 9000|
|Principal Investigator:||Luc Van Bortel, MD, PhD||University Hospital, Ghent|