Pharmacokinetic Study of Two Generic co-Formulations of Lopinavir/Ritonavir for HIV Infected Children (SURF)
This pilot pharmacokinetic study is designed to exclude a large difference (>40%) in pharmacokinetics (esp. AUC) between two new Lopimune formulations and the branded formulation. The formal bioequivalence study with adequate power will be conducted by the manufacturer. In order to get data independently from the manufacturer and to have this information in an earlier phase, this small pilot study is initiated.
The initial study showed a declined bioavailability of the granules under fasting conditions. The study has been extended with an arm determining the pharmacokinetics of the granules after food (compared to the oral solution taken with food).
|Study Design:||Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||The Pharmacokinetics of Two Generic co-Formulations of Lopinavir/Ritonavir for HIV Infected Children: a Pilot Study of Lopimune vs. the Branded Product (SURF Study).|
- Plasma concentrations of lopinavir and ritonavir. [ Time Frame: 0 (predose), 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 24 and 32 hours post ingestion (11 samples) on Days 1, 8 and 15. ] [ Designated as safety issue: No ]
- safety: adverse events [ Time Frame: entire study ] [ Designated as safety issue: Yes ]
|Study Start Date:||September 2008|
|Study Completion Date:||February 2009|
|Primary Completion Date:||February 2009 (Final data collection date for primary outcome measure)|
Active Comparator: A
Lopinavir/ritonavir 200/50mg; 2 tablets; single dose
Other Name: Kaletra
Lopinavir/ritonavir 100/25mg; 4 sachets with granules; single dose
Other Name: Lopimune granules
Lopinavir/ritonavir 100/25mg; 4 tablets; single dose
Other Name: Lopimune tablets
Cipla has developed two co-formulated forms of lopinavir/ritonavir for second-line antiretroviral therapy for children: Lopimune granules and Lopimune tablets. They contain 100mg lopinavir and 25mg ritonavir.
Primary objective of this study:
To determine the pharmacokinetic profile of lopinavir and ritonavir in two different co-formulations (Lopimune granules and Lopimune tablets) after single-dose in HIV-negative, healthy adult subjects, and to compare this to the branded product.
To evaluate the safety of single-dose administration of the two generic co-formulations of lopinavir/ritonavir and compare this to the branded product.