CTRI/2021/09/036727招募中不适用
A randomised, open label, two-period, multiple dose cross-over bioavailability study between the test product, Pirfenidone ER tablet 1200 mg (Cipla Ltd., India) administered as one tablet twice daily with the reference product PIRFENEX (pirfenidone) 200 mg tablet (Cipla Ltd., India) administered as four tablets thrice daily in healthy adult human subjects at steady state under fed conditions.
Cipla Ltd India1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年1月8日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Cmax,ss Cmin,ss and AUC(0-t)ss for pirfenidone.
研究概览
简要总结
This study is randomised, open label,two-period, multiple dose cross-over bioavailability study between the testproduct, Pirfenidone ER tablet 1200 mg (Cipla Ltd., India) administered as onetablet twice daily with the reference product PIRFENEX (pirfenidone) 200 mg tablet(Cipla Ltd., India) administered as four tablets thrice daily in healthy adulthuman subjects at steady state under fed conditions. Primary objective of thestudy is to compare the rate and extent of absorption of pirfenidone afteradministration of multiple doses of the test product and reference product.Secondary objective is to assess the safety and tolerability of multiple oraldoses of test and reference product in healthy adult human subjects under fedconditions.
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.
- •2.Volunteers who are healthy adult between 18 to 45 years of age (both inclusive) of Asian Indian origin.
- •3.Volunteers have a body mass index (BMI) between 18.5 and 30 Kg per metre square, 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 study.
- •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 study.
- •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 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 study.
- •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 study.
- •12.Volunteers agree to avoid sun exposure from check-in till post study.
- •13.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.
- •14.Volunteers agree to refrain from driving or operating machinery till 24 hours after discharge from CPU.
- •15.Volunteers whose test for COVID 19 is negative (if available).
- •1.For female volunteers: i.Negative beta Hcg or urine pregnancy test report showing non pregnancy.
- •ii.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 to 1 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 (Evra or equivalent), vaginal ring (NuvaRing or equivalent), levonorgesterel implant (Norplant or equivalent), or injectable progesterone (Depo Provera or equivalent) 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.
排除标准
- •1.Volunteers who have history of known hypersensitivity to pirfenidone or related drugs.
- •2.Volunteers having difficulty in swallowing tablet.
- •3.Volunteers with history of known food allergy.
- •4.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) at pre-study screening and at vital signs examination before check-in.
- •5.Volunteers having any medical or surgical conditions, which might significantly interfere with the functioning of gastrointestinal tract.
- •6.Volunteers who have clinically significant signs and symptoms or history of respiratory, cardiovascular, gastrointestinal, dermatological, neurological, psychiatric, genitourinary, endocrinological, musculoskeletal, bleeding disorder, tumor or cancer, eye, ear, nose, and throat disease.
- •7.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.
- •8.Volunteers having Estimated Glomerular Filtration Rate (eGFR) less than 60 mL per min per 1.73 metre square calculated by MDRD (Modification of Diet in Renal Disease Study) formula.
- •9.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.
- •10.Volunteers who have taken any drug that induces or inhibits the hepatic microsomal enzymes (including omeprazole and rifampicin) 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 having 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 venipuncture, evidence of skin lesions on forearm or signs of venipuncture on the forearm suggestive of recent blood donation or participation in a study.
- •17.Female volunteers who have clinically significant signs and symptoms or history of gynaecological disease.
结局指标
主要结局
Cmax,ss Cmin,ss and AUC(0-t)ss for pirfenidone.
时间窗: Test | Day1to4 0.00,(-96,-84, -72,-60,48,-36, -24,-12 hrs) | Day5to6: 0.00,2,4,5,6,6.5,7,8,10,12,14,16,17,18, 18.5,19,20,22,24,30,36 hrs. | Reference | Day 1 to 4: 0.00 (-96,-88,-80,-72,-64,-56,-48,-40,-32,-24,-16,-8 hrs) | Day 5 to 6: 0.00,1,2,3,3.5,4,5,6,8,9,10,11,11.5,12,13,14,16,17,18,19,19.5,20,2,22,24,30,36 hrs.
次要结局
- Cpd, Ctau.ss, Cavg ss, Tmax.ss, AUC0-24 hours, % fluctuation, % swing(Test)
研究者
研究点 (1)
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