A randomised, single dose, open label, three-period, cross-over, comparative bioavailability study between the test product, Remdesivir oral solution 100 mg/5 mL (Cipla Ltd., India) and the reference product, CIPREMI (Lyophilised) Remdesivir for injection 100 mg/ vial) (Cipla Ltd., India) in healthy adult male human subjects under fasting conditions.

Cipla Ltd India1 个研究点分布在 1 个国家目标入组 16 人开始时间: 2021年9月8日最近更新: 2021年9月28日

试验速览

阶段: 不适用
状态: Other
发起方
入组人数: 16
试验地点: 1
主要终点: AUC 0 t and AUC 0 inf for Remdesivir

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This study is A randomised, single dose, open label, three-period, cross-over, comparative bioavailability study between the test product, Remdesivir oral solution 100 mg/ 5 mL (Cipla Ltd., India) and the reference product, CIPREMI (Lyophilised) Remdesivir for injection 100 mg/ vial) (Cipla Ltd., India) in healthy adult male human subjects under fasting conditions. Safety of the study subjects will also be monitored andevaluated. Remdesivir is available as an injection for treatment of Covid 19. Cipla proposed to develop oral formulation to increase compliance and ease of administration of the medication. As per data available in literature Remdesivir has near complete first pass effect. Hence period one and two will be conducted to evaluate the bioavailability of oral Remdesivir.

研究设计

研究类型: Interventional
分配方式: Computer generated randomization
盲法: Open Label

入排标准

年龄范围: 18.00 Year(s) 至 45.00 Year(s)（—）
性别: Male

入选标准

•1.Volunteers who give consent by signing the informed consent form after understanding the study related information about the nature, risk, and scope of the clinical study as well as the expected adverse effects of the drug.
•2.Volunteers who are healthy adult between 18 to 45 years of age (both inclusive) of Asian Indian origin.
•3.Volunteers who have a Body Mass Index between 18.5 and 30 kg/m2, weighing not less than 45 kg.
•4.Volunteers who have no evidence of any significant diseases or clinically significant abnormal findings during the pre-study screening, medical and medication histories, vital signs examination, physical examination, 12-lead electrocardiogram (ECG) and chest X-ray (postero-anterior view recorded in last 180 days).
•5.Volunteers, whose urine alcohol test and urine test for drugs of abuse are negative and whose Rapid Plasma Reagin (RPR), Hepatitis B Surface Antigen (HBsAg), Hepatitis C (Anti HCV) and antibodies to human immuno-deficiency Virus (HIV) I and II are negative or non-reactive.
•6.Volunteers whose pre-study screening laboratory tests are within normal limit or clinically not significant.
•7.Volunteers who have agreed to follow the appropriate distancing, all the necessary safety precautions like wearing mask, using hand sanitizer etc.
•during the study.
•8.Volunteers who agree to abstain from consuming grapefruit or its products for at least 72 hours prior to dosing and until the last blood sample collection of each study period.
•9.Volunteers who agree to abstain from consuming citrus fruits or their products and xanthine containing products (chocolate, tea, coffee or cola drink), for at least 24 hours prior to dosing and until the last blood sample collection of each study period.
•10.Volunteers who do not have history of drug addiction or a habit of heavy drinking which is defined as regular intake of more than 2 units of alcohol per day for males (1 unit is equal to 150 mL of wine or 360 mL of beer or 45 mL of 40 percent alcohol) and those who agree to abstain from consuming alcohol or alcoholic products for at least 48 hours prior to dosing and until the last blood sample collection of each study period.
•11.Volunteers who are non-smokers or those who are ex-smokers and have less than a 10 pack-year history of smoking and have not consumed tobacco or tobacco containing products for at least 12 months prior to screening and who agree to abstain from the same until the last blood sample collection of the last treatment period.
•12.Volunteers must agree to be available for the entire study and have the ability to understand and communicate effectively with the investigators and study personnel.
•13.Volunteers whose test for COVID-19 is negative.

排除标准

•1.Volunteers who have history of known hypersensitivity to Remdesivir or related class of drug.
•2.Volunteers with history of a known food allergy.
•3.Volunteers who have vital signs abnormalities (systolic blood pressure less than 100 or greater than 140 mm of Hg or diastolic blood pressure less than 60 or greater than 90 mm of Hg or pulse rate less than 50 beats per minute or more than 100 beats per minute) during pre-study screening and vital signs examination before check-in.
•4.Volunteers having any medical or surgical conditions, which might significantly interfere with the functioning of gastrointestinal tract.
•5.Volunteers who have recent history of dehydration from diarrhoea, vomiting or any other reason within a period of 24 hours prior to the study check-in.
•6.Volunteers having Estimated Glomerular Filtration Rate (eGFR) less than 60 mL/min/1.73 m2 calculated by MDRD (Modification of Diet in Renal Disease Study) formula.
•7.Volunteers who have clinically significant signs and symptoms or history of respiratory, cardiovascular, gastrointestinal, dermatological, neurological, psychiatric, genitourinary, endocrinological, musculoskeletal, bleeding disorder, tumor/ cancer, eye, ear, nose and throat disease.
•8.Volunteer with febrile illness within 1 week before start of the study.
•9.Volunteers who have suffered any clinically significant illness in the 2 weeks prior to dosing or who have been hospitalised within 3 months preceding the start of the study.
•10.Volunteers who have taken any drug that induces/inhibits the hepatic microsomal enzymes (including chloroquine phosphate and hydroxychloroquine sulfate) within 30 days prior to dosing.
•11.Volunteers who have taken any prescription medication or over-the-counter products available (including vitamins and products from natural origin such as ayurvedic, unani, siddha and homeopathic medicines) and topical medication meant for systemic absorption, within the 7 days prior to dosing.
•12.Volunteers who have depot injection or an implant of any drug within 3 months prior to dosing.
•13.Volunteers who have a history of difficulty in donating blood.
•14.Volunteers who have donated blood (1 unit or 350 mL) within 90 days prior to dosing.
•15.Volunteers who have taken any investigational product or participated in any drug research study requiring blood donation within 90 days prior to dosing.
•16.Volunteers who have unsuitable veins for repeated venepuncture, evidence of skin lesions on forearm or signs of venepuncture on the forearm suggestive of recent blood donation or participation in a study.

结局指标

主要结局

AUC 0 t and AUC 0 inf for Remdesivir

时间窗: Predose, 0.25, 0.33, 0.50, 0.67, 1.00, 1.33, 1.67, 2.00, 2.50, 3.00, 3.50, 4.00, 5.00, 6.00, 8.00, 10.00, 12.00, 16.00, 24.00, 48.00, 72.00, 96.00 and 120.00 hours post-dose

次要结局

Cmax,Tmax, T1 by 2, Residual area, Kel, Vd, Cl for Remdesivir(AUC 0 t and AUC 0 inf, Cmax,Tmax, T1 by 2, Residual area, Kel, Vd, Cl for GS 441524 and GS 704277 (metabolite))

研究者

发起方

Cipla Ltd India

申办方类型

Pharmaceutical industry-Indian

研究点 (1)

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