TCTR20170830001已完成1 期
A Single Dose, Randomized, Open-label, Two-way Crossover Bioequivalence Study of Generic Tadalafil 20 mg Film-coated Tablets and Reference Product (CIALIS®) in Healthy Thai Male Volunteers under Fasting Condition
International Bio Service Co., Ltd.0 个研究点目标入组 26 人开始时间: 2017年8月30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 tadalafil, sildenafil, vardenafil or other selective inhibitors of PDE-5 or any of the excipients of this product
- •2History or evidence of clinically significant renal, hepatic, gastrointestinal, hematological, endocrine (e.g. thyroid), pulmonary or respiratory (e.g. asthma), psychiatric, neurologic (e.g. depression, insomnia), 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 cardiovascular disease e.g. heart failure, stroke, myocardial infarction, unstable angina, arrhythmias, hypotention or hypertention
- •4History or evidence of vision disorder or genetic vision disorder e.g. decreased vision or loss of vision etc.
- •5History or evidence of anatomical deformation of the penis (e.g. angulation) or priapism
- •6History or evidence of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption
- •7History of problems with swallowing tablet
- •8History of sensitivity to heparin or heparin-induced thrombocytopenia
- •9Any condition possibly affecting drug absorption e.g. oral mucous membrane lesions, gastrectomy, enterectomy, gastritis or duodenal or gastric ulceration other than appendectomy
- •10History of dehydration from diarrhea, vomiting, excess sweating or any other reasons within 24 hours prior to admission or prior to dosing in each period
- •11History or evidence of drug addict or investigation with urine sample shows a positive test for drug of abuse (morphine, marijuana or methamphetamine).
- •12Have sitting systolic blood pressure of less than 90 mmHg or more than 139 mmHg and diastolic blood pressure of less than 60 mmHg or more than 89 mmHg on screening day and the day of admission. If abnormal blood pressure detects, the measurement should be repeated two more times after take a rest for at least 5 mins each. The last measurement value should be used to determine the subject’s eligibility.
- •13Investigation of vital signs shows pulse rate less than 60 or more than 100 beats per minute on screening day or on the day of admission. If abnormal pulse rate detects, the measurement should be repeated two more times after take a rest for at least 5 minutes each. The last measurement value should be used to determine the subject’s eligibility.
- •1412-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.
- •15Investigation with blood sample shows positive test for HBsAg.
- •16Abnormal liver function, ≥ 1.5 times of upper normal limit of reference range for ALT, AST or bilirubin levels at screening laboratory test
- •17Have renal creatinine clearance (CrCl) ≤ 80 mL/min based on serum creatinine results at the screening laboratory test
- •18History 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
- •19History or evidence of alcoholism,
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