A randomised, single dose, open label, two-period, 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 under fed conditions.

Cipla Ltd India0 个研究点目标入组 60 人开始时间: 待定最近更新: 2022年10月17日

试验速览

阶段: 未知
状态: 已完成
发起方
入组人数: 60

研究概览入排标准研究者记录与标识符相似试验

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)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 meter 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 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 and 1 unit for females (1 unit is equal to 150 mL of wine or 360 mL of beer or 45 mL of 40percent 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 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).
•16.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 equal to or less than 1 year post menopausal or Surgically sterile ( tubal ligation, oophorectomy or hysterectomy

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/ 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/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.

研究者

发起方

Cipla Ltd India

相似试验

进行中（未招募）

不适用

A research study to find out whether a product to be tested (salmeterol xinafoate HFA pMDI 25 µg per actuation, manufactured by Cipla Ltd, India) is equivalent to the already existing formulation (salmeterol xinafoate HFA pMDI 25 µg per actuation (Serevent Evohaler™), supplied by Allen and Hanburys, UK) when administered by a volumatic spacer device to children with asthmaMedDRA version: 17.1Level: PTClassification code 10003553Term: AsthmaSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersAsthma

EUCTR2014-001946-10-BGCipla Ltd.80

尚未招募

不适用

Bioequialence study of two novel strengths of Coartem

CTRI/2011/12/002256ovartis Healthcare Pvt Ltd120

进行中（未招募）

1 期

Clinical trial in Healthy Volunteers to test Valsartan PharmacokineticsHypertension

EUCTR2016-004323-23-Outside-EU/EEAovartis86

已完成

1 期

A study to compare the concentrations of valsartan in plasma when valsartan is taken as solution formulation and as tablet formulation.

CTRI/2010/091/001094ovartis Healthcare Private Limited Andhra Pradesh India30

已完成

不适用

Randomized, Open Label, Single-Dose, Two Period, Two Treatment, Two Sequence, Cross-over, Study to Compare the Pharmacokinetics, Pharmacodynamics and Safety of Rabeprazole Sodium Delayed-release Capsule 20 mg in Healthy Volunteers.

CTRI/2017/07/008985Cadila Healthcare Limited12