TCTR20210205002尚未招募1 期
An Open Label, Randomized, Two-Treatment, Two-Period, Single Oral Dose, Crossover Bioequivalence Study of FAVIR of The Government Pharmaceutical Organization, Thailand with AVIGAN of FUJIFILM TOYAMA CHEMICAL CO., LTD., Japan, in Normal, Healthy, Adults Human Subjects under Fasting Conditions
适应症
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 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
- All
入选标准
- •1.Be healthy male and female subjects between 18-55 years of age (both inclusive).
- •2.Have a Body Mass Index (BMI) between 18.0-30.0 (both inclusive), calculated as weight in kg/height in m2.
- •3.Have no evidence of underlying disease or clinically significant abnormal finding during screening, medical history examination, physical examination.
- •4.Have no abnormal finding during laboratory examination such as complete blood count, hematocrit, hemoglobin, fasting blood sugar, blood urea nitrogen (BUN), blood uric acid serum creatinine, alkaline phosphatase, ALT, AST, total bilirubin, total protein, albumin, HBsAg, Anti-HCV, Anti-HIV, urine analysis, chest X-ray and 12-Lead ECG recording or judged by physician as clinically insignificant or acceptable.
- •5.Able to understand and comply with the study procedures, in the opinion of the Principal Investigator.
- •6. Able to give voluntary written inform consent for participation in the trial.
- •7. In case of female subjects:
- •7.1 Females of child-bearing potential agree to use an acceptable method of birth control for entire duration of the study as judge by the investigator(s):
- •7.1.1Non hormonal intrauterine device in place of at least 3 months prior to the start of the study and remaining in place during the study period, or
- •7.1.2 Barrier methods containing or used in conjunction with a spermicidal agent, such as condoms, foams, jellies, diaphragm, etc., or
- •7.1.3Surgery sterilization or
- •7.1.4 Practicing sexual abstinence throughout the course of the study.
- •7.2 Females were not considered of childbearing potential if one of the following was reported and documented on the medical history:
- •7.2.1Postmenopausal with spontaneous amenorrhea for at least one year, or
- •7.2.2 Bilateral oophorectomy with or without a hysterectomy and an absence of bleeding for at least 6 months, or
- •7.2.3 Total hysterectomy and absence of bleeding for at least 3 month.
- •7.3 Females demonstrate a negative pregnancy test performed at screening.
- •7.4 Females without currently breast-feeding.
排除标准
- •1. Any history of hypersensitivity to favipiravir or any of its excipients.
- •2. A recent history or presence of any disease or condition which might compromise the haemopoietic (i.e. gout), renal, hepatic, endocrine, pulmonary, central nervous, cardiovascular, immunological, dermatological, gastrointestinal or any other body system.
- •3. Clinically significant illness within 4 weeks before the start of the study.
- •4. Any history of bronchospasm, asthma, urticaria or other allergic type reactions after taking any medication.
- •5. A positive hepatitis screen including HBsAg and/or anti-HCV.
- •6. A positive test result for anti-HIV.
- •7.Has participated in any other clinical trial involving drug administration and collection of blood samples or has donated blood (1 unit or 350 mL) in the preceding 90 days prior to the start of the study.
- •8. History of difficulty with donating blood or difficulty in accessibility of veins.
- •9.A recent history of harmful use of alcohol (less than 2 years) i.e., alcohol consumption of more than 14 standard drinks per week for men and 7 standard drinks per week for women (A standard drink is defined as 360 ml of beer or 150 ml of wine or 45 ml of 40% distilled spirits, such as rum, whisky, brandy etc), or consumption of alcohol or alcoholic product within 48 hours prior to dosing, or testing positive in pre-study breath test for alcohol consumption.
- •10.Consumption of grapefruit, pomelo, orange, or any products containing these fruits within 48 hours prior to dosing.
- •11. Consumption of xanthine containing products (i.e. tea, coffee, chocolates or cola drinks) more than 3 cups/day or consuming these products within 24 hours prior to dosing.
- •12.Heavy smoking (10 cigarettes/day)
- •13.Moderate smoking (10 cigarettes/day) and consumption of tobacco-containing products, which cannot stop smoking or consuming 24 hours prior to dosing and for entire duration of the study.
- •14.Use of any recreational drugs or history of drug addiction or testing positive in pre-study drug scans.
- •15.Consumption of any medication (including over-the-counter products, herbal remedies), or vitamins, or dietary supplements at any time within 14 days prior to dosing. In any such case subject selection will be at the discretion of the Principal Investigator.
研究者
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