A Phase I, open label, randomized, crossover trial in healthy subjects to investigate the pharmacokinetic interaction between didanosine and TMC114, coadministered with low-dose ritonavir, at steady-state. - An interaction study of TMC114 combined with ritonavir with didanosine

Tibotec Pharmaceuticals0 个研究点目标入组 18 人开始时间: 待定最近更新: 2024年6月18日

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•1. Male or female subjects, aged between 18 and 55 years, extremes included.
•2. 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.
•3. Normal weight as defined by a Quetelet Index (Body Mass Index: weight in kg divided by the square of height in meters) of 18.0 to 30.0 kg/m2, extremes included17 (and of a minimum weight of 60 kg).
•4. Informed Consent Form (ICF) signed voluntarily before the first trial-related activity.
•5. Able to comply with protocol requirements.
•6. Healthy on the basis of a medical evaluation that reveals the absence of any clinically relevant abnormality and includes physical examination (including skin examination), medical history, electrocardiogram, vital signs and the results of blood biochemistry, hematology and blood coagulation tests and a urinalysis carried out at screening.

•- History or evidence of current use of alcohol
•- A positive urine drug test at screening
•- Participation in an investigational drug trial within 90 days prior to the first intake of trial medication
•- Having previously participated in a multiple-dose trial with TMC114
•- Having previously participated in more than one single-dose trial with TMC114
•- Blood or plasma drawn or donated within 60 days prior to the screening visit
•- A positive HIV-1 or HIV-2 test at study screening
•- Hepatitis A, B or C infection
•- A positive pregnancy test or breast feeding at screening
•- History of significant drug allerby such as, but not limited to, sulfonamides and penicillines
•- Use of concomitant medication, including over-the-counter products and dietary supplements. All concomitant medication must have been discontinued at least 14 days prior to the first intake of trial medication, except for paracetamol (acetaminophen), which may be used up to 3 days before the first dose of trial medication
•- Not suitable to participate in the trial according to the opinion of the investigator

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