Innovation-TiFP4-C101: A Study to Evaluate the Pharmacokinetics of TMC114 and TMC41629 After a Single Oral Dose of 2 Controlled-release Coformulations as Compared to an Immediate-release Coformulation of TMC114/TMC41629
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|ClinicalTrials.gov Identifier: NCT00854204|
Recruitment Status : Completed
First Posted : March 3, 2009
Last Update Posted : April 28, 2010
|Condition or disease||Intervention/treatment||Phase|
|HIV-I||Drug: TMC114; TMC41629||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I, Open-label, 3-way Crossover Trial in Healthy Male Volunteers to Evaluate the Pharmacokinetics of TMC114 and TMC41629 After a Single Oral Dose of 2 Controlled-release Coformulations as Compared to an Immediate-release Coformulation of TMC114/TMC41629|
|Study Start Date :||November 2008|
|Primary Completion Date :||January 2009|
|Study Completion Date :||January 2009|
- Plasma levels of TMC114 and TMC41629 will be determined up to 72 hours after administration.
- To determine short-term safety and tolerability of TMC114/TMC41629 following administration of 3 single oral doses (formulated as different coformulations of TMC114/TMC41629).
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): NCT00854204
|Study Director:||Tibotec Pharmaceuticals Limited Clinical Trial||Tibotec Pharmaceutical Limited|