HIV-1 Infection
Conditions
Interventions
During 4 sessions each subject will receive in a randomized way 4 single doses
of 200 mg TMC125: two tablets of 100 mg formulated as F060 (Treatment A,
Reference, non-coated tablets), two tablets of
Sponsors
Janssen-Cilag
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Permission in writing to participate in this trial; Aged between 18 and 55 years; A good physical and mental condion; Normal weight for your length; No abnormalities found at screening; Non-smoking; Females should be post-menopausal for at least 2 years, or have had a hystorectomy, or tubal ligation (without reversal operation).
Exclusion criteria
Exclusion criteria: if you use of drugs and/or have a history of alcohol abuse; If you have had a have had a surgical operation in the past three months; If you have developed a rash as a result of participation in another trial with TMC125/TMC120/TMC278; If you have participated in another medical trial within the past three months; If you have doneted blood within the past 60 days; If you are hepatitis A, B, C or HIV-1 or HIV-2 positive; If you are in the opinion of the physician not fit to participate in this trial; If you used prescription medication in the 14 day before admission; If oyu used over the counter drugs in the 7 days before intake of the trial medication. This includes herbal suplements, dieting suplements, garlic suplements and vitamines ( except for paracetamol and ibuprefen, which can be used up to 3 days before first intake of trial mediaction); Any history of significant skin disease such as, but not limited to, rash or eruptions, drug allergies, food allergy, dermatitis, eczema, psoriasis, or urticaria.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| In each session, full pharmacokinetic profiles of TMC125 will be determined up to 96 hours after administration. Safety and tolerability will be assessed on an ongoing basis until 30 - 32 days after last drug intake. Blood and urine tests, adverse events, safety laboratory parameters, vital signs, heart rate, ECG, alcohol breath tests, urine drug screen tests and pregancy test (female only). | — |
Secondary
| Measure | Time frame |
|---|---|
| Not applicable. | — |
Countries
Netherlands
Outcome results
None listed