Status:
COMPLETED
TMC278-TiDP38-C145: A Bioavailability Study in Healthy Adult Volunteers to Evaluate 3 Pediatric Formulations of TMC278 (a Solution, a Suspension, and Granules) Compared to an Adult Tablet Formulation
Lead Sponsor:
Tibotec Pharmaceuticals, Ireland
Conditions:
Pharmacokinetics
Bioavailability
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to evaluate how much and how fast a single, oral, daily 25 mg dose of TMC278 is absorbed into the body when administered as a solution, suspension, granules, or a tablet. ...
Detailed Description
This is an open-label (both investigator and volunteer knows the name of the assigned study medication), randomized (study medication will be assigned by chance) cross-over study in healthy adults to ...
Eligibility Criteria
Inclusion
- Non-smoking or smoking no more than 10 cigarettes, or 2 cigars, or 2 pipes per day for at least 3 months prior to selection
- A Body Mass Index (BMI, weight in kg divided by the square of height in meters) of 18.0 to 30.0 kg/m2, extremes included
- Informed Consent Form signed voluntarily before the first trial-related activity
- Able to comply with protocol requirements
- Healthy on the basis of a medical evaluation that reveals the absence of any clinically relevant abnormality and includes a physical examination, medical history, electrocardiogram, vital signs, and the results of blood biochemistry and hematology tests and a urinalysis carried out at screening.
Exclusion
- A positive HIV-1 or -2 test at trial screening
- Female, except if postmenopausal since more than two years, or post-hysterectomy or post-tubal ligation (without reversal operation)
- One or more risk factors for QTc prolongation
- Currently active gastrointestinal, cardiovascular, neurologic, psychiatric, metabolic, renal, hepatic, respiratory, inflammatory or infectious disease
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2009
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT00812292
Start Date
January 1 2009
End Date
April 1 2009
Last Update
June 9 2011
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.