CTRI/2021/09/036729 [Registered on: 22/09/2021] Trial Registered Prospectively
Last Modified On:
30/05/2022
Post Graduate Thesis
No
Type of Trial
BA/BE
Type of Study
Study Design
Randomized, Crossover Trial
Public Title of Study
Bioavailability study between Pirfenidone ER tablet 1200 mg and PIRFENEX (pirfenidone) 200 mg tablet in healthy human subjects
Scientific Title of Study
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.
Trial Acronym
Secondary IDs if Any
Secondary ID
Identifier
21-03-050 Version 01 Date 10 May 2021
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Muneesh Garg
Designation
Principal Investigator
Affiliation
Sitec Labs Ltd.
Address
PEE-DEE Infotech, Plot No. Gen-40 TTC MIDC, Near Nelco, Behind Millennium Business Park, Mahape, Navi Mumbai
Thane MAHARASHTRA 400710 India
Phone
919833913773
Fax
Email
muneesh.garg@siteclabs.com
Details of Contact Person Scientific Query
Name
Dr Hemant Joshi
Designation
Senior Manager
Affiliation
Cipla Ltd
Address
Clinical Research and Development R and D Centre North Block LBS Marg Vikhroli West
Mumbai MAHARASHTRA 400083 India
Phone
919823066463
Fax
Email
hemant.joshi2@cipla.com
Details of Contact Person Public Query
Name
Dr Hemant Joshi
Designation
Senior Manager
Affiliation
Cipla Ltd
Address
Clinical Research and Development R and D Centre North Block LBS Marg Vikhroli West
Mumbai MAHARASHTRA 400083 India
Phone
919823066463
Fax
Email
hemant.joshi2@cipla.com
Source of Monetary or Material Support
Cipla House, Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel, Mumbai-400013, Maharashtra, India
Primary Sponsor
Name
Cipla Ltd India
Address
Cipla House, Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel, Mumbai-400013, Maharashtra, India
Type of Sponsor
Pharmaceutical industry-Indian
Details of Secondary Sponsor
Name
Address
NIL
NIL
Countries of Recruitment
India
Sites of Study
No of Sites = 1
Name of Principal
Investigator
Name of Site
Site Address
Phone/Fax/Email
Dr Muneesh Garg
Sitec Labs Ltd.
PEE-DEE Infotech, Plot No. Gen-40, TTC MIDC, Near Nelco, Behind Millennium Business Park, Mahape, Navi Mumbai
Thane MAHARASHTRA
919833913773
muneesh.garg@siteclabs.com
Details of Ethics Committee
No of Ethics Committees= 1
Name of Committee
Approval Status
Suraksha Ethics Committee
Approved
Regulatory Clearance Status from DCGI
Status
No Objection Certificate
Health Condition / Problems Studied
Health Type
Condition
Healthy Human Volunteers
healthy adult between 18 to 45 years of age who have a Body Mass Index between 18.5 and 30 kg/m2 weighing not less than 45 kg
Intervention / Comparator Agent
Type
Name
Details
Comparator Agent
PIRFENEX (pirfenidone) 200 mg tablet
PIRFENEX (pirfenidone) 200 mg tablet (Cipla Ltd., India) administered as four tablets thrice daily
Dose - Single oral dose of four PIRFENEX (pirfenidone) 200 mg tablet thrice daily in each period.
Mode of administration - To be administered orally with 240±2 mL of water under fed conditions.
Intervention
Pirfenidone ER tablet 1200 mg
Pirfenidone ER tablet 1200 mg (Cipla Ltd., India)
Dose -Single oral dose of one Pirfenidone ER tablet 1200 mg twice daily in each period.
Mode of administration - To be administered orally with 240±2 mL of water under fed conditions.
Inclusion Criteria
Age From
18.00 Year(s)
Age To
45.00 Year(s)
Gender
Both
Details
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) 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 1percent 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.
ExclusionCriteria
Details
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.
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Pre-numbered or coded identical Containers
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
AUC0-24 hours, AUC0-t and AUC0-∞ of pirfenidone for the test product relative to the reference product
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
This study is 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. In this our primary objective is 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 oral dose of Pirfenidone 2400 mg tablets in healthy adult human subjects under fed conditions.