CTRI/2022/05/042589尚未招募不适用
A randomised, open label, two-treatment, two-period, cross-over, single dose oralbioequivalence study between test product, Nirmatrelvir 300mg (2 x 150 mg)tablets and Ritonavir 100 mg tablet (Cipla Ltd., India) and the reference product,PAXLOVID (Nirmatrelvir 300mg [2 x 150 mg] tablets and Ritonavir 100 mgtablet) (Distributed By: Pfizer labs, Division of Pfizer Inc. New York, NY10017)in healthy adult human subjects under fasting conditions.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Cmax, AUC0-t and AUC0-infinity
研究概览
简要总结
A randomised, open label, two-treatment, two-period, cross-over, single dose oral bioequivalence study between test product, Nirmatrelvir 300mg (2 x 150 mg) tablets and Ritonavir 100 mg tablet (Cipla Ltd., India) and the reference product,
PAXLOVID (Nirmatrelvir 300mg [2 x 150 mg] tablets and Ritonavir 100 mg tablet) (Distributed By: Pfiznr labs, Division of Pfizer Inc. New York, NYl0017) in healthy adult human subjects under fasting conditions.
To compare the rate and extent of absorption of the test product and reference product. Secondary objective is to assess the safety and tolerability of single dose of Nirmatrelvir and Ritonavir 300/100 mg Tablet in healthy adult human subjects.
Bioequivalence will be concluded if the confidence interval so constructed fall within the range of 80–125% for (ln-transformed) Cmax and AUC0-t for nirmatrelvir.
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
- All
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.
- •Volunteers who are healthy adult between 18 to 45 years of age both inclusive of Asian Indian origin.
- •Volunteers who have a Body Mass Index between 18.5 and 30 kg per meter square, weighing not less than 45 kg.
- •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.
- •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.
- •Volunteers whose pre-study screening laboratory tests are within normal limit or clinically not significant.
- •Volunteers who have agreed to follow the appropriate distancing, all the necessary safety precautions like wearing mask, using hand sanitizer etc.
- •during the study.
- •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.
- •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.
- •Volunteers who do not have history of drug addiction or habit of heavy drinking which is defined as regular intake of more than 2 units of alcohol per day for males and 1 unit for females, 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.
- •Volunteers who are non-smokers or those who are ex-smokers with less than 10 pack-year history 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.
- •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.
- •Volunteers who agree to avoid driving vehicles and operating machines 24 hours after discharge from clinical facility.
- •Volunteers whose test for COVID-19 is negative.
- •For female volunteers: i.
- •non pregnant as per pregnancy test.
- •who is currently not pregnant, breast feeding, or attempting to be pregnant from the screening visit and throughout the duration of the study, and is of Non-childbearing, defined as more than or equal to1 year post-menopausal or Surgically sterile, tubal ligation, oophorectomy or hysterectomy or Diagnosed as infertile and not undergoing treatment to reverse infertility or is of Child-bearing potential, willing to commit to using a consistent and acceptable method of birth control as defined below for the duration of the study: Systemic contraception used from the time of screening including birth control pills, transdermal patch, vaginal ring, levonorgesterel implant Norplant or equivalent), or injectable progesterone or Double barrier methods condoms, cervical cap, diaphragm, and vaginal contraceptive film with spermicide or Intrauterine device IUD with a low failure rate less than 1 percent per year or is of Child-bearing potential and not sexually active, willing to commit to using a consistent and acceptable method of birth control as defined above for the duration of the study, in the event the subject become sexually active.
- •prior to screening and who agree to abstain from the same until the last blood sample collection of the last treatment period.
排除标准
- •Volunteers who have history of known hypersensitivity to nirmatrelvir and ritonavir or related class of drug.
- •Volunteers having difficulty in swallowing tablet.
- •Volunteers with history of a known food allergy.
- •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.
- •Volunteers with history of acute pancreatitis.
- •Volunteers with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, glucose-galactose malabsorption or severe lactase deficiency.
- •Volunteers having any medical or surgical conditions, which might significantly interfere with the functioning of gastrointestinal tract.
- •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.
- •Volunteers who have clinically significant signs and symptoms or history of respiratory, cardiovascular, gastrointestinal, dermatological, renal, hepatic, neurological, psychiatric, genitourinary, endocrinological, musculoskeletal, bleeding disorder, tumor or cancer, eye, ear, nose and throat disease.
- •Volunteers who have suffered any clinically significant illness in the 2 weeks prior to dosing or who have been hospitalized within 3 months preceding the start of the study.
- •Volunteers who have suffering from active skin infection.
- •Volunteers who have taken any drug that induces or inhibits the hepatic microsomal enzymes within 30 days prior to dosing.
- •Volunteers who have taken any prescription medication, including apalutamide, anticonvulsants, antifungal, rifampin, St. Johns Wort 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.
- •Volunteers who have depot injection or an implant of any drug within 3 months prior to dosing.
- •Volunteers who have a history of difficulty in donating blood.
- •Volunteers who have donated blood,1 unit or 350 mL within 3 months prior to dosing.
- •Volunteers having Estimated Glomerular Filtration Rate less than 60mL per min per 1.73metre square calculated by Modification of Diet in Renal Disease Study formula.
- •Volunteers who have taken any investigational product or participated in any drug research study requiring blood donation within 90 days prior to dosing.
- •Volunteers who have unsuitable veins for repeated venipuncture, evidence of skin lesions on forearm or signs of venipuncture on the forearm suggestive of recent blood donation or participation in a study.
- •Female volunteers who have clinically significant signs and symptoms or history of gynaecological disease.
结局指标
主要结局
Cmax, AUC0-t and AUC0-infinity
时间窗: Sampling time points are 0.00, 0.33, 0.67, 1.00, 1.33, 1.67, 2.00, 2.25, 2.50, 2.75, 3.00, 3.25, 3.50, 3.75, | 4.00, 4.50, 5.00, 6.00, 8.00, 10.00, 12.00, 24.00 and 36.00 hours post-dose.
次要结局
- Tmax, T1/2, Residual area (%): Extrapolated area [(AUC0-∞ - AUC0-t)/ AUC0-∞] x 100 and Kel(Sampling time points are 0.00, 0.33, 0.67, 1.00, 1.33, 1.67, 2.00, 2.25, 2.50, 2.75, 3.00, 3.25, 3.50, 3.75,)
研究者
研究点 (1)
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