Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2025-12-24 @ 11:40 PM
NCT ID:
NCT00665951
Brief Summary:
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).
Detailed Description:
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.
Secondary objective:
To evaluate the safety of single-dose administration of the two generic co-formulations of lopinavir/ritonavir and compare this to the branded product.
Study:
NCT00665951
Study Brief:
Protocol Section:
NCT00665951