Ignite Creation Date:
2024-05-05 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00470041
Status:
COMPLETED
Last Update Posted:
2010-06-16
First Post:
2007-05-04
Brief Title:
Bioavailability Study of a New Pediatric Formulation of ZidovudineLamivudine in Adult Volunteers
Sponsor:
University Ghent
Organization:
University Ghent
Study Overview
Official Title:
Bioavailability Study of a New Pediatric Formulation of ZidovudineLamivudine in Adult Volunteers
Status:
COMPLETED
Status Verified Date:
2010-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 12 healthy volunteers will receive in a cross-over design two formulations ie 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
Interventions 12 healthy volunteers will receive in a cross-over design two formulations ie 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None