CTRI/2021/04/033072招募中未知
Absolute Bioavailability Study of Lupins Remdesivir Oral solution 100mg/5mL with Remdesivir for injection 100mg/20mL, in healthy, adult, human male subjects under fasting condition for the oral dose optimization and assessment of bioequivalence
upin Limited Research Park0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Ba/be
入排标准
入选标准
- •1. Healthy, human male subjects aged between 18 and 45 years (inclusive of both).
- •2. Subjects with a BMI between 18.50-30.00 kg/m2 (inclusive of both) and body mass not less than 50.00 kg.
- •3. Subjects in normal health as determined by personal medical history,clinical examination including vital signs and clinically acceptable
- •results of laboratory examinations (including serological tests).
- •4. Subjects having a normal or clinically not significant 12-lead electrocardiogram (ECG) recording.
- •5. Subjects having a normal or clinically not significant chest X-Ray (P/A view).
- •6. A negative urine screen result for drugs of abuse (including amphetamines, barbiturates, benzodiazepines, marijuana, cocaine and morphine).
- •7. A negative alcohol urine test result.
- •8. A negative COVID-19 RTPCR result before each check in.
- •8. Subject able to communicate effectively and provide written informed consent.
- •9. Subjects willing to adhere to the protocol requirements as evidenced by written informed consent approved by ethics committee.
- •10.Subjects that can provide adequate evidence of their identity.
- •11. Male agreeing to use appropriate contraceptive measures like Double Barrier method (Condom).
- •12. Availability of volunteer for the entire study duration.
- •13. Ability to fast for at least 14.00 hours and consume standard meals.
排除标准
- •1. Known hypersensitivity to Remdesivir or related drugs or any component of this medication.
- •2. Incapable of understanding the informed consent information.
- •3. History or presence of significant cardiovascular, pulmonary, hepatic, renal (estimated e GFR < 60mL/min), gastrointestinal, endocrine, immunological, dermatological, neurological or psychiatric disease or disorder.
- •4. Any treatment which could bring about induction or inhibition of hepatic microsomal enzyme system within one month of starting the
- •5. History or presence of alcoholism or drug abuse.
- •6. History or presence of asthma, urticaria or other allergic reactions.
- •7. History or presence of gastric and/or duodenal ulceration.
- •8. History or presence of thyroid disease, adrenal dysfunction, organic intracranial lesion.
- •9. History or presence of cancer
- •10. Difficulty with donating blood.
- •11. Use of any prescribed medication (including herbal remedies) during the two weeks before the start of the study or OTC medicinal Products
- •(including herbal remedies) during the week prior to study initiation and throughout the study.
- •12. Smokers who smoke 9 or more cigarettes/day or inability to abstain during the study.
- •13. Subject consumed tobacco/ tobacco containing products, pan or pan masala, gutkha, masala ( containing beetle nut and tobacco) for at least 48.00 hours prior to initiation of the study and throughout the study.
- •14. Subject consumed caffeine and /or xanthine-containing foods or beverages (i.e. coffee, tea, chocolate, and caffeine-containing sodas,
- •colas, etc.) and grape fruit juice and poppy containing foods for at least 48.00 hours prior to initiation of the study and throughout the study.
- •15. Major illness during the 90 days before screening.
- •16. Participation in a drug research study within 90 days of screening.
- •17. Donation of blood within 90 days of screening.
- •18. Positive screening test result for any one or more of the following: HIV, Hepatitis B, Hepatitis C and VDRL.
- •19. History or presence of easy bruising or bleeding.
- •20. Abnormal diet pattern for whatever reason ( e.g. low sodium, fasting, and high protein diets) during the four weeks preceding the study.
- •21. Male volunteer willing to donate sperms during the study till 09 days after the completion of study.
研究者
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