A Phase I, open-label, randomized, 2-way crossover trial in 2 parallel panels of 20 healthy subjects each to investigate the pharmacokinetic interaction between lopinavir/ritonavir (LPV/rtv) and telaprevir, and between atazanavir/ritonavir (ATV/rtv) and telaprevir, all at steady-state. - An interaction study of telaprevir in combination with LPV/rtv or ATV/rtv

Tibotec Pharmaceuticals0 个研究点目标入组 40 人开始时间: 待定最近更新: 2024年5月13日

试验速览

暂无简介。

•1. Permission in writing from volunteer to participate in this trial
•2. Age 18-55 years
•3. In good physical and mental health
•4. Normal weight length ratio (BMI 18-30 kg/m2);
•5. Women should be postmenopausal for at least 2 years, or have undergone a hysterectomy, or have had a tubal ligation (without reversal operation)
•6. No significant abnormalities will be found at screening
•7. Non smoking or smoking no more than 10 cigarettes, or 2 cigars, or 2 pipes per day for at least 3 months before study screening

•1. History of alcohol or drug abuse within 2 years prior to dosing
•2. Eye disorder at admission
•3. Current or past relevant disease concerning the cardio vascular system, respiratory system, kidneys, liver, blood, hormone system, nervous system, immunological system, skin or psychiatric condition
•4. Having an illness within 5 day prior to receiving the first dose of study medication, e.g. nausea, vomiting, flu,
•5. In the opinion of the physician any relevant abnormality on your ECG
•6. Any medical condition which is of influence on the absorption, distribution, metabolism and excretion of the study medication
•7. Use of over the counter drugs within 14 day of dosing, including herbal supplements (except for paracetamol and vitamins)
•8. Use of prescription medication within 30 days before dosing
•9. Have had an relevant allergic reaction on medication
•10. Use of grapefruit or grapefruit containing, alcohol, caffeine containing products
•11. products 48 hours before admission
•12. Participation in a clinical trial within 2 months before dosing
•13. Donation of blood within three months before dosing
•14. Hepatitis B, C or HIV positive
•15. If in the opinion of the physician the volunteer is not suitable to participate in this trial.

发起方