Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06588517
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-09-06
Brief Title:
Comparative PharmacokineticPK Study of Pirfenidone Modified-Release Tablets and Pirfenidone Tablets in Healthy Subjects Under Fed Conditions
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Randomized Open-Label Two-Period Double-Crossover Comparative Study on the Pharmacokinetics of Pirfenidone Modified-Release Tablets and Pirfenidone Tablets in Healthy Chinese Subjects Under Fed Conditions
Status:
COMPLETED
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A Randomized Open-Label Two-Period Double-Crossover Comparative Study on the Pharmacokinetics of Pirfenidone Modified-Release Tablets and Pirfenidone Tablets in Healthy Chinese Subjects under Fed Conditions Primary objective To evaluate the bioequivalence of test product and reference product by comparing their plasma concentrations and main PK parameters by oral administration in healthy Chinese subjects under fed conditions using Pirfenidone Modified-Release Tablets strength 600 mgtablet developed by Overseas Pharmaceuticals Ltd as the test product and Pirfenidone Tablets trade name Pirespa strength 200 mgtablet produced by Shionogi amp Co Ltd as the reference product Secondary objective To evaluate the safety of Pirfenidone Modified-Release Tablets test product and Pirfenidone Tablets reference product after oral administration in healthy Chinese subjects under fed conditions
Detailed Description:
It is designed to be a single-center randomized open-label two-period double-crossover trial All subjects must sign an informed consent form ICF prior to participation in the trial Twenty-four 24 eligible healthy subjects male and female with an appropriate sex ratio screened through physical examination from D-14 to D-1 of dosing will be randomized into Group T-R and Group R-T with 12 subjects in each group The enrolled subjects will be admitted to phase I ward of the clinical study site 1 day before medication in each period and fasted for more than 10 h before medication
On the morning of medication after the collection of blank blood samples within 60 minutes before administration both group will have a standard breakfast that completed within 10 min30 s Group T will orally take 1 tablet of Pirfenidone Modified-Release Tablets 600 mgtablet Overseas Pharmaceuticals Ltd developed by Overseas Pharmaceuticals Ltd in 12 minutes after starting a standard breakfast Group R will orally take 3 tablet of Pirfenidone Modified-Release Tablets 600 mgtablet Overseas Pharmaceuticals Ltd under fed conditionThe first tablet should be taken in 12 minutes after the start of a standard breakfast the second tablet should be taken in 30 minutes 30 s after the start of a standard lunch and the third tablet should be taken in 30 minutes 30 s after the start of a standard dinner
Standard lunch is served 4 h after administration standard dinner 10 h later water is prohibited before and within 1 h after administration except 240 mL water for medication and unified diet is required during the trial
Unified diet is required during the trial The trial method in period II is the same as that in period I with a washout period of 6 days
PK blood sampling and blood sample processing
Cubital venous blood will be collected at 31 time points before administration 0 h and 025 h 050 h 100 h 150 h 200 h 300 h 400 h 450 h 500 h 600 h 700 h 750 h 800 h 900 h 1000 h 1025 h 1050 h 1100 h 1150 h 1200 h 1250 h 1300 h 1400 h 1600 h 1800 h 2000 h 2400 h 2800 h 3600 h and 4800 h after administration of each period
Four milliliters 4 mL scale of 4 mL should be pre-marked on the blood collection tube will be drawn and placed in a labeled EDTA-2K anticoagulant tube The collection processing and storage procedures of biological samples are subject to the final sample operation manual Sitting vital signs including respiratory rate body temperature pulse rate and sitting blood pressure will be measured within 1 h before administration and at 2 05 h 8 05 h 24 05 h and 48 1 h after administration Subjects should receive physical examination vital signs ECG and laboratory-related tests on D2 after the last dose The subjective feelings of subjects as well as possible adverse reactions ARs and adverse events AEs occurred during the trial should be observed and inquired All subjects will be followed up for 7 days after the end of the last dose to inquire the occurrence of any subsequent AEs If occurred AEs should be recorded and followed up An AE emerged during the trial should be followed up until it is resolved
On the morning of medication after the collection of blank blood samples within 60 minutes before administration both group will have a standard breakfast that completed within 10 min30 s Group T will orally take 1 tablet of Pirfenidone Modified-Release Tablets 600 mgtablet Overseas Pharmaceuticals Ltd developed by Overseas Pharmaceuticals Ltd in 12 minutes after starting a standard breakfast Group R will orally take 3 tablet of Pirfenidone Modified-Release Tablets 600 mgtablet Overseas Pharmaceuticals Ltd under fed conditionThe first tablet should be taken in 12 minutes after the start of a standard breakfast the second tablet should be taken in 30 minutes 30 s after the start of a standard lunch and the third tablet should be taken in 30 minutes 30 s after the start of a standard dinner
Standard lunch is served 4 h after administration standard dinner 10 h later water is prohibited before and within 1 h after administration except 240 mL water for medication and unified diet is required during the trial
Unified diet is required during the trial The trial method in period II is the same as that in period I with a washout period of 6 days
PK blood sampling and blood sample processing
Cubital venous blood will be collected at 31 time points before administration 0 h and 025 h 050 h 100 h 150 h 200 h 300 h 400 h 450 h 500 h 600 h 700 h 750 h 800 h 900 h 1000 h 1025 h 1050 h 1100 h 1150 h 1200 h 1250 h 1300 h 1400 h 1600 h 1800 h 2000 h 2400 h 2800 h 3600 h and 4800 h after administration of each period
Four milliliters 4 mL scale of 4 mL should be pre-marked on the blood collection tube will be drawn and placed in a labeled EDTA-2K anticoagulant tube The collection processing and storage procedures of biological samples are subject to the final sample operation manual Sitting vital signs including respiratory rate body temperature pulse rate and sitting blood pressure will be measured within 1 h before administration and at 2 05 h 8 05 h 24 05 h and 48 1 h after administration Subjects should receive physical examination vital signs ECG and laboratory-related tests on D2 after the last dose The subjective feelings of subjects as well as possible adverse reactions ARs and adverse events AEs occurred during the trial should be observed and inquired All subjects will be followed up for 7 days after the end of the last dose to inquire the occurrence of any subsequent AEs If occurred AEs should be recorded and followed up An AE emerged during the trial should be followed up until it is resolved
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None