TCTR20170712003已完成未知
A single Dose, Randomized, Open-label, Two-way Crossover Bioequivalence Study of Generic Finasteride 1 mg Film-coated Tablets (FINASTERIDE, BANGKOK LAB & COSMETIC CO.,LTD.,Thailand) and Reference Product (PROPECIA, MSD International GmBH (Puerto Rico
International Bio Service Co., Ltd.0 个研究点目标入组 26 人开始时间: 2017年7月12日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 26
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 Years 至 55 Years（—）
- 性别
- Male
入选标准
- •1 Healthy Thai male subjects between the ages of 18 to 55 years
- •2 Body mass index between 18 to 25 kg/m2
- •3 Normal laboratory values including vital signs and physical examination for all parameters in clinical laboratory tests at screening
- •Any abnormalities from the normal or reference range will be carefully considered clinically relevant by the physician as individual cases documented in study files prior to enrolling the subject in this study
- •4 Subjects who are willing or able to use effective contraceptive e.g. condom or abstinence after admission in Period 1 until 7 days after the end of study
- •5 Have voluntarily given written informed consent (signed and dated) by the subject prior to participating in this study
排除标准
- •1 History of allergic reaction or hypersensitivity to finasteride or related structure (e.g. testosterone) to any of the components of the product
- •2 History or evidence of clinically significant renal, hepatic, gastrointestinal, hematological, endocrine e.g. thyroid, pulmonary, cardiovascular, phychiatric, neurologic or allergic disease (including drug allergies but excluding untreated, asymptomatic, seasonal allergies at time of dosing) or any significant ongoing chronic medical illness
- •3 History or evidence of reproductive system disorders e.g. erectile dysfunction or ejaculation disorders
- •4 History or evidence of phychiatric disorder e.g. anxiety, depression occurring within the 2 years prior to admission that required hospitalization or medication
- •5 History or evidence of galactose intolerance the Lapp lactase deficiency or glucose galactose malabsorption
- •6 History of problems with swallowing tablets
- •7 History of sensitivity to heparin or heparin induced thrombocytopenia
- •8 Any condition possibly affecting drug absorption e.g. gastrectomy, enterectomy, gastritis or duodenal or gastric ulceration other than appendectomy
- •9 History of preceding diarrhea within 24 hours prior to admission in each period
- •10 History or evidence of drug addict or investigation with urine sample shows a positive test for drug of abuse (morphine, marijuana or methamphetamine)
- •11 12 lead ECG demonstrating QTc> 450 msec, a QRS interval> 120 msec or with an abnormality considered clinically significant at screening If QTc exceeds 450 msec or QRS exceeds 120 msec the ECG should be repeated two more times and the average of the three QTc or QRS values should be used to determine the subject's eligibility
- •12 Investigation with blood sample shows positive test for HBsAg
- •13 Abnormal liver function >=1.5 times of upper normal limit of reference range for ALT AST or bilirubin levels at screening laboratory test
- •14 History or evidence of habitual use of tobacco or nicotine containing products and cannot abstain for at least 7 days prior to admission and continued until last sample collection in each study period
- •15 History or evidence of alcoholism, regular alcohol consumption or alcohol containing products and cannot abstain for at least 7 days prior to admission and continued until last sample collection in each study period
- •16 History or evidence of habitual consume of tea coffee xanthine or caffeine containing products and cannot abstain for at least 7 days prior to admission and continued until last sample collection in each study period
- •17 Consumption or drinking of grapefruit juice or orange or its supplement containing products and cannot abstain for at least 7 days prior to admission and continued until last sample collection in each study period
- •18 Use of prescription or nonprescription drugs (e.g. minoxidil, paracetamol, antacid, ibuprofen, erythromycin, ketoconazole etc.), herbal medications or supplements (e.g. St.John's wort), vitamins, or iron or dietary supplements within 14 days prior to admission in Period 1 or during enrollment
- •19 Participated in other clinical trials within 90 days or ongoing long-term clinical trial prior to admission in Period 1 (except for the subjects who dropout/withdrawn from the previous study prior to Period 1 dosing) or during enrollment
- •20 Blood donation or blood loss >= 1 unit (1 unit is equal t
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