EUCTR2008-006738-85-GB进行中（未招募）不适用
A Single Dose, Open-Label, Randomized, Two-Way Crossover Food Effect Study Comparing 12.5 mg FazaClo™ (clozapine) ODT under Fasted and Fed Conditions in Healthy Male Volunteers.
Azur Pharma, Ltd.0 个研究点目标入组 24 人开始时间: 2008年11月10日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 24
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Male
入选标准
- •-Adult males aged 18-45 years inclusive and between 19-30 kg/m2 body mass index.
- •-Subjects who are healthy as determined by pre-study medical history, physical examination, 12 Lead ECG (QTc upper limit 430 ms), 24 hour Holter ECG monitoring (screening) and EEG (screening).
- •-Subjects whose clinical laboratory test results are not clinically relevant and are acceptable to the Investigator.
- •-Subjects who are negative for hepatitis B surface antigen (HBsAg), hepatitis C antibody and human immunodeficiency virus (HIV) I and II tests at screening.
- •-Subjects who are negative for drugs of abuse and alcohol tests at screening and admission.
- •-Subjects who are non-smokers for at least 3 months preceding screening.
- •-Subjects who are able and willing to give written informed consent.
- •-Medical history must be verified by either a personal physician or medical practitioner as appropriate.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •-Subjects who do not conform to the above inclusion criteria.
- •-Subjects who have a clinically relevant history or presence of respiratory, gastrointestinal, renal, hepatic, haematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, connective tissue diseases or disorders.
- •-Subjects who have a clinically relevant surgical history.
- •-Subjects who have a clinically relevant family history including a history of cardiomyopathy and /or QT prolongation in first degree relatives.
- •-Subjects who have a history of relevant atopy.
- •-Subjects who have a history of relevant drug hypersensitivity.
- •-Subjects who have a history of alcoholism.
- •-Subjects who have a history of drug abuse.
- •-Subjects who consume more than 21 units of alcohol a week. (unit = 1 glass of wine (125 mL) = 1 measure of spirits = ½ pint of beer).
- •-Subjects who have a significant infection or known inflammatory process on screening.
- •-Subjects who have acute gastrointestinal symptoms at the time of screening or admission (e.g. nausea, vomiting, diarrhoea, heartburn).
- •-Subjects who have an acute infection such as influenza at the time of screening or admission.
- •-Subjects who have used prescription drugs within 4 weeks of first dosing.
- •-Subjects who have used over the counter medication excluding routine vitamins but including megadose (intake of 20 to 600 times the recommended daily dose) vitamin therapy within 7 days of first dosing, unless agreed as non clinically relevant by the Principal Investigator and Sponsor.
- •-Subjects who have used any investigational drug in any clinical trial within 3 months of receiving the last dose.
- •-Subjects who have received the last dose of investigational medicinal product (IMP) greater than 3 months ago but who are on extended follow-up.
- •-Subjects who are vegetarians, vegans or have medical dietary restrictions.
- •-Subjects who have a total white blood cell (WBC) count below 4.0 x109/L or an absolute neutrophil count below 2.5 x109/L.
- •-Subjects who have a history or family history of glaucoma.
- •-Subjects who cannot communicate reliably with the Investigator.
- •-Subjects who are unlikely to co-operate with the requirements of the study.
研究者
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