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

NCT06569381 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2025-03-20

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Pirfenidone Modified-Release Tablets

take the tablet under fasting condition, 1 tablet at a time, once a day.

DRUG

Pirfenidone Modified-Release Tablets

take the tablet under fed condition, 1 tablet at a time, once a day.

Sponsors & Collaborators

  • Shanghai ShouYan Clinical Development Co.,Ltd.

    collaborator UNKNOWN

  • Overseas Pharmaceuticals, Ltd.

    lead INDUSTRY

Principal Investigators

  • Yu Cao, Doctor · The Affiliated Hospital of Qingdao University

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-09-18
Primary Completion
2024-10-01
Completion
2024-12-08
FDA Drug
Yes

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06569381 on ClinicalTrials.gov