Comparative Pharmacokinetic Study of Pirfenidone Modified-Release Tablets in Healthy Subjects Under Fasting and Fed Conditions

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 Pharmacokinetics (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.

Timeline

Start

2024-09-18

Primary completion

2024-10-01

Completion

2024-12-08

Drugs

Indications