NL-OMON32773已完成不适用
Phase I, open-label, randomized, crossover trial in healthy adults to compare the oral bioavailability of 3 concept pediatric formulations of TMC278 (solution, suspension, granules) to that of the adult 25 mg Phase III tablet formulation, and to assess the food effect for each concept formulation. - Phase I trial with 3 concept pediatric formulations of TMC278.
Tibotec Pharmaceuticals, EastGate Village, Eastgate, Little Island, CO Cork, Ireland, In Nederland vertegenwoordigd door Janssen-Cilag B.V.0 个研究点目标入组 36 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 36
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1) Age between 18 and 55 years
- •2) Non-smoking or smoking no more than 10 cigarettes, or 2 cigars, or 2 pipes a day for at least 3 months prior to selection.
- •3) BMI 18.0-30.0.
- •4) Signed ICF
- •5) Able to comply with protocol requirements
- •6) Healthy based on the basis of a medical evaluation.
排除标准
- •1) Positive HIV and Hepatitis testresults.
- •2) Female except if they are of non-childbearing potential.
- •3) History or evidence of alcohol and or drug abuse.
- •4) Hepatitis A, B en C
- •5) Positive urine drug test
- •6) Currently active or underlying gastrointestinal, cardiovascular, neurologic, psychiatric, metabolic, renal, hepatic, respiratory, inflammatory or infectious disease.
- •7) Currently significant diarrhea, gastric stasis or constipation that in the investigator's opinion could influence drug absorption or bioavailability.
- •8) Any history of significant skin disease such as but not limited to rash or eruptions, drug allergies, food allergy, dermatitis, eczema, psoriasis or urticaria.
- •9) Previously demonstrated clinically significant allergy or hypersensitivity to and/or any of the excipients of the investigational medication administered on this trial.
- •10) Use of concomitant medication, including over-the-counter products and dietary supplements. Systemic over-the-counter medication must have been discontinued at least 7 days prior to the first dose of study medication; prescribed medications must have been discontinued at least 14 days before the first dose of study medication, except for paracetamol and ibuprofen.
- •11) Participation in an investigational drug trial within 60 days prior to the first intake of trial medication.
- •12) Donation of blood plasma within the 60 days preceding the first intake of trial medication.
- •13) Lab abnormalities
- •14) Having participated in more than 1 trial (single or multiple dose) with TMC125 (etravine), TMC120 (dapirivine) and/or TMC278 (rilpivirine, formerly known as R278474) or having developed rash, erythema or urticaria while participating in a trial with the aforementioned compounds.
- •15) Significant heart rhythm disturbances.
- •16) Subjects with ageusia, hypogeusia or dysgeusia
- •17) Renal impairment: calculated creatinine clearance (CLCr) < 80 mL/min;
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