A Phase I randomized, open-label, single dose, 4-period crossover study in healthy subjects to evaluate the relative oral bioavailability of two tablet strengths of TMC125 and the effect of coating on bioavailability. - 4-period cross-over study with TMC125

Janssen-Cilag0 个研究点目标入组 24 人开始时间: 待定最近更新: 2024年5月13日

适应症

试验速览

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•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).

•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.

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