TCTR20170121002已完成1 期
Open Label, Randomized, Two-way Crossover, Two-sequence, Two-period, Two-treatment Bioequivalence Study of 5 mg Finasteride Film-coated Tablet Preparations in Healthy Thai Male Volunteers
International Bio Service Co., Ltd.0 个研究点目标入组 26 人开始时间: 2017年1月21日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 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
- •1Healthy Thai male subjects between the ages of 18 to 55 years.
- •2Body mass index between 18.0 to 25.0 kg/m2.
- •3Normal 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.
- •4Male 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.
- •5Have voluntarily given written informed consent (signed and dated) by the subject prior to participating in this study.
排除标准
- •1History of allergic reaction or hypersensitivity to finasteride or related structure (e.g. testosterone) or any of the components of the product
- •2History or evidence of clinically significant renal, hepatic, gastrointestinal, hematological, endocrine (e.g. thyroid), pulmonary, cardiovascular, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) or any significant ongoing chronic medical illness
- •3History or evidence of reproductive system disorders e.g. prostate cancer, erectile dysfunction or ejaculation disorders
- •4History or evidence of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption
- •5History of problems with swallowing tablet
- •6History of sensitivity to heparin or heparin-induced thrombocytopenia
- •7Any condition possibly affecting drug absorption e.g. gastrectomy, enterectomy, gastritis or duodenal or gastric ulceration other than appendectomy
- •8History of preceding diarrhea within 24 hrs prior to admission in each period
- •9History or evidence of drug addict or investigation with urine sample shows a positive test for drug of abuse (morphine, marijuana or methamphetamine)
- •1012-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.
- •11Investigation with blood sample shows positive test for HBsAg.
- •12Abnormal liver function, ≥ 1.5 times of upper normal limit of reference range for ALT, AST or bilirubin levels at screening laboratory test
- •13History 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.
- •14History 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
- •15History 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
- •16Consumption 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
- •17Use of prescription or nonprescription drugs (e.g. paracetamol, erythromycin, ibuprofen, ketoconazole), herbal medications or supplements (e.g. St. John’s wort), vitamins or mineral (e.g. iron) or dietary supplements within 14 days prior to admission in Period 1 or during enrollment
- •18Participated in other clinical trial within 90 days or ongoing long-term clinical trial prior to admission in Period 1 (except for the subjects who dropped out/withdrawn from the previous study prior to Period 1 dosing) or during enrollment
- •19Blood donation or blood loss ≥1 unit (1 unit is equal to 350-450 mL of blood) within 90 days prior to admission in Period 1 or during enrollment
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