A Phase I randomized, open-label, single dose, 3-period crossover trial in healthy subjects to evaluate the relative oral bioavailability of the 25 mg and 100 mg tablets of TMC125.
- Conditions
- AIDSHIV10047438
- Registration Number
- NL-OMON30258
- Lead Sponsor
- TIBOTEC Pharmaceuticals Ltd., Little Island, Co. Cork; Ireland in Nederland vertegenwoordigd door Janssen-Cilag BV
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 36
Inclusion Criteria
Participants may not have smoked for the last 3 months preceding the start of the trial. Participants have to be healthy on base of physical examination, medical history, ECG, laboratory tests and blood pressure and pulse rate.
Exclusion Criteria
Participants may not have (had) relevant skin diseases or use medicines. The participants may not have participated in more than 1 study with TMC125, TMC120 and/or TMC278 (previously R278474) or having developed rash while participating in a trial with any of these compounds. Females may not be fertile anymore.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Pharmacokinetic analysis, blood and urine examination, side-effects (adverse<br /><br>events), laboratory results, blood pressure, pulse rate, ECG, alcohol breath<br /><br>test. </p><br>
- Secondary Outcome Measures
Name Time Method <p>not applicable</p><br>