TCTR20231103004尚未招募1 期
Bioequivalence Study of 10 mg Macitentan Film-coated Tablets in Healthy Thai Male Volunteers
nison Laboratories Co., Ltd.0 个研究点目标入组 30 人开始时间: 2023年11月3日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
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 or female volunteers aged between 18 and 55 years. 2. The Body Mass Index (BMI) ranges from 18.5 to 25 kg/m2. 3. Determined healthy by medical history, physical examination and vital signs 4. The results of the clinical laboratory tests are within clinically acceptance limits i.e., blood urea nitrogen (BUN), serum creatinine, AST, ALT, total bilirubin, alkaline phosphatase, GGT, blood potassium, sodium, calcium, chloride, fasting blood sugar and hematology examinations including differential blood counts and HBsAg test. Some of the clinical laboratory values that out of the normal range will be carefully considered by clinical investigator. 5. Male volunteers who are surgically sterile or agree to use an effective contraception throughout the study. 6. Willing to participate in the study and signed the informed consent form.
排除标准
- •1. History or evidence of allergy or hypersensitivity to macitentan or any of the excipients of this product or any related drugs. 2. History or evidence of allergy or hypersensitivity to heparin. 3. History or evidence of hypertension (systolic BP 140 mmHg, diastolic BP 90 mmHg) or hypotension (systolic BP <90 mmHg, diastolic BP <60 mmHg). 4. History or evidence of gastrointestinal, hepatic, renal, cardiovascular, hemato-logical disease or allergic disease or bronchial asthma or any disease that may affect the bioavailability of drug. 5. Evidence of more than one abnormal ECG which is considered as clinically significant. 6. History of chronic or debilitating diseases. 7. Positive HBsAg tests. 8. History of alcoholism or drug abuse. 9. Positive urine drug abuse tests (Benzodiazepines, Methamphetamine and Opi-ates). 10. History of regular alcohol consumption (more than 1 time a week) or alcohol consumption within 7 days prior to the study drug administration and until the completion of the study. 11. History of smoking more than 10 cigarettes/day, or moderate smokers (less than 10 cigarettes/day) and could not quit at least 7 days prior to the study drug administration and until the completion of the study. 12. Tea/coffee or caffeine- or xanthine-containing beverage consumption within 7 days prior to the study drug administration and until the completion of the study. 13. Grapefruit juice or grapefruit-containing products consumption within 7 days prior to the study drug administration and until the completion of the study. 14. Use of any prescription drugs or over-the-counter (OTC) drugs or herbal medi-cines within 30 days or vitamins or food supplements within 14 days prior to the study drug administration 15.Blood donation or blood loss over 350 mL within 90 days before the study. 16. Participation in any clinical studies within 90 days before the study.
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