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 @ 9:07 PM
Ignite Modification Date:
2025-12-24 @ 9:07 PM
NCT ID:
NCT00854204
Brief Summary:
The purpose of this study is to compare the bioavailability (the degree to which a drug becomes available in the body after administration) of 3 different pharmaceutical preparations of a combination of two drugs, TMC114 and TMC41629. There will be 1 single oral intake (intake by mouth) of each of the 3 preparations. The study will also investigate the safety of use and the potential side effects of TMC114 and TMC41629, and determine the circulating levels of both compounds in your blood over time (pharmacokinetics), after a single intake.
Detailed Description:
TMC41629 is a new investigational drug for the treatment of HIV. TMC114, is also known as Darunavir. In this randomized (study medication assigned by chance), open label trial (investigator and healthy volunteer know the name of the study medication), each healthy volunteer will receive a single dose of TMC114/TMC41629, in 3 subsequent sessions, Treatment A, Treatment B and Treatment C. Each capsule is equivalent to a dose of 200 mg of TMC114 and 23.67 mg of TMC41629. Treatment A (immediate-release formulation) will serve as reference formulation. All medication intakes will be orally and in fasted conditions.The study duration is at least 19 days, excluding screening and follow-up visits with three single intakes with 72 hours follow-up per intake. Each volunteer will receive a single dose of each formulation. TMC114/TMC41629 is formulated as an oral immediate-release hard-gelatin capsule, as an oral gastro-resistant hard-gelatin capsule, enteric-coated and as an oral gastro-resistant hard-gelatin capsule, colon-targeted. Each capsule is equivalent to a dose of 200 mg of TMC114 and 23.67 mg of TMC41629.
Study:
NCT00854204
Study Brief:
Protocol Section:
NCT00854204