Comparative Pharmacokinetic Study of Pirfenidone Modified-Release Tablets in Healthy Subjects Under Fasting and Fed Conditions
NCT Number: NCT06569381
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Idiopathic Pulmonary Fibrosis
Interventions: DRUG: Pirfenidone Modified-Release Tablets|DRUG: Pirfenidone Modified-Release Tablets
Sponsor: Overseas Pharmaceuticals, Ltd.
Collaborators: Shanghai ShouYan Clinical Development Co.,Ltd.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 18
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-08-23
Completion Date: 2024-12-24
Locations: The Affiliated Hospital of Qingdao University, Qingdao, Shandong, 266000, China

Summary:
A Randomized, Open-Label, Single-Dose, Double-period, Double-Crossover Comparative Study on the Pharmacokinetics of Pirfenidone Modified-Release Tablets by Oral Administration in Healthy Chinese Subjects Under Fasting and Fed Conditions.

Primary objective:

To evaluate the food effect on test product by comparing their plasma concentrations and main PK parameters by oral administration of test product in healthy Chinese subjects under fasting and fed conditions using Pirfenidone Modified-Release Tablets (strength: 600 mg/tablet) developed by Overseas Pharmaceuticals, Ltd. as the test product.

Secondary objective: To evaluate the safety of Pirfenidone Modified-Release Tablets (test product) by oral administration in healthy Chinese subjects under fasting and fed conditions.

Primary Outcome Measures: Peak concentration at each treatment period (Cmax,tp), The 90% CI for the geometric mean ratios (i.e., antilog-transformation for 90% CI of difference with log transformation)of Cmax,tp within \[0.8, 1.25\] range will be used to determine the result of bioequivalence., 1 month|Area under the curve from time zero to the time of the last quantifiable plasma concentration of the period (AUC0-last), The 90% CI for the geometric mean ratios (i.e., antilog-transformation for 90% CI of difference with log transformation) of AUC0-last within \[0.8, 1.25\] range will be used to determine the result of bioequivalence., 1 month|Area under the curve from time zero to infinity (AUC0-inf), The 90% CI for the geometric mean ratios (i.e., antilog-transformation for 90% CI of difference with log transformation)of AUC0-inf within \[0.8, 1.25\] range will be used to determine the result of bioequivalence., 1 month
Secondary Outcome Measures: Time to reach peak concentration of the first dosing (Tmax), Individual pirfenidone and 5-carboxyl-pirfenidone plasma concentration-time profile for each treatment period will be established., 1 month|Terminal half-life (T1/2), Individual pirfenidone and 5-carboxyl-pirfenidone plasma concentration-time profile for each treatment period will be established., 1 month|elimination rate constant（λz）, The PK parameters of each subject were calculated for statistical analysis, 1 month|residual area in percentage（AUC_%Extrap）, The PK parameters of each subject were calculated for statistical analysis, 1 month|apparent clearance（CL/F）, The PK parameters of each subject were calculated for statistical analysis, 1 month|apparent volume of distribution（Vd/F）, The PK parameters of each subject were calculated for statistical analysis, 1 month|Lag time (tlag), The PK parameters of each subject were calculated for statistical analysis, 1 month