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

NCT06589921 | Completed Phase 1 FDA Drug

• 1 other identifier: YY-BFNT-2023
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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 mg/tablet) developed by Overseas Pharmaceuticals, Ltd. as the test product and Pirfenidone Tablets (trade name: Pirespa®, strength: 200 mg/tablet) produced by Shionogi \& 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.

Conditions

Idiopathic Pulmonary Fibrosis

Keywords

Pirfenidone; Modified-Release; Idiopathic pulmonary fibrosis; Healthy Volunteers

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• Peak concentration at each treatment period (Cmax,tp)

  1 month

• Peak concentration of the first dosing (Cmax)

  1 month

• Time to reach peak concentration of the first dosing (Tmax)

  1 month

• Terminal half-life (T1/2)

  1 month

• Elimination rate constant（λz）

  1 month

Study Arms (2)

Group T

EXPERIMENTAL

take the tablet under fed condition ,1 tablet at a time, once a day.Test product (T): Pirfenidone Modified-Release Tablets Strength: 600 mg/tablet Batch No.: 08532 Content: 600 mg/tablet Valid to: January/2025 Storage Conditions: sealed at normal temperature (10-30°C) Manufacturer: Overseas Pharmaceuticals, Ltd.

Drug: Pirfenidone Modified-Release Tablets

Group R

ACTIVE COMPARATOR

take the tablet under fed condition ,1 tablet at a time, three times a day.Reference product (R): Pirfenidone Tablets Strength: 200 mg/tablet Batch No.: 0239 Content: 200 mg/tablet Valid to: September 2026 Storage Conditions: sealed at room temperature Manufacturer: Shionogi \& Co., Ltd.

Drug: Pirfenidone Tablets

Interventions

Pirfenidone Modified-Release Tablets DRUG

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

Group T

Pirfenidone Tablets DRUG

ake the tablet under fed condition, 1 tablet at a time, three times a day.

Group R

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy male and female subjects over the age of 18 years (including those aged 18 years), with an appropriate sex ratio;
• Male subjects with a body weight ≥ 50.0 kg, and female subjects with a body weight ≥ 45.0 kg; BMI (BMI = body weight (kg)/\[height (m)\]2) within the range of 19-26.0 kg/m2 (including the critical value);
• Subjects with good health conditions, no clinically significant medical history in respiratory system, circulatory system, digestive system, urinary system, blood system, endocrine system, immune system, nervous system, and mental system;
• Subjects (including partners) who have no plans of pregnancy and voluntarily take appropriate contraceptive measures from the date of signing the informed consent (14 days before signing the informed consent for female subjects) to 6 months after the end of the study;
• Subjects who are able to communicate well with the investigator and understand and adhere to the study requirements. Subjects who fully understand the objective, nature, method and possible ARs of the trial, voluntarily act as subjects, and sign the ICF before any study procedures are started;

You may not qualify if:

• Patients with an allergic history to the study drug or its excipients (such as lactose), or an allergic history to drug, food , pollen or a specific allergic history (asthma, allergic rhinitis, eczema);
• Patients with a history of photosensitivity and existing skin irritation symptoms such as rash and pruritus;
• Subjects who have special dietary requirements and cannot accept a unified diet;
• Subjects with a history of dysphagia or any gastrointestinal disorder affecting drug absorption;
• Subjects who cannot tolerate venipuncture and have a history of fear of needles and hemophobia;
• Subjects with clinically significant hematological, endocrine, cardiovascular, hepatic, renal and pulmonary disorders that may affect drug absorption, distribution, metabolism and excretion;
• Subjects with a surgical history or taking the study drug or participating in other drug clinical trials within 3 months prior to the study;
• Subjects with blood donation or massive blood loss (\> 450 mL) within 3 months before the study;
• Subjects taking special diet (including pitaya or grapefruit and products containing grapefruit ingredients) or having strenuous exercise within 7 days before taking the study drug, or having other factors affecting drug absorption, distribution, metabolism and excretion;
• Subjects administered with any prescription drugs, over-the-counter, herbal, or health products within 14 days prior to taking the study drug;
• Regular drinkers within 6 months prior to the study, i.e., drinking more than 14 units of alcohol per week (1 unit = 360 mL of beer or 45 mL of spirit containing 40% alcohol or 150 mL of wine);
• Subjects smoking more than 5 cigarettes per day in the first 3 months of the study; Or positive results of tobacco test;
• Subjects who have consumed chocolate, any caffeine-containing, or xanthine-rich food or beverage, such as coffee, strong tea, and cola 48 h before taking the study drug;
• Subjects having taken any alcohol-containing products within 48 h before taking the study drug, or having a positive result for alcohol screening;
• Female subjects with positive pregnancy test or lactating during the screening period or during the trial;

Sponsors & Collaborators

• Overseas Pharmaceuticals, Ltd.: lead

Study Sites (1)

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, 266000, China

Location

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis

Interventions

pirfenidone

Condition Hierarchy (Ancestors)

Pulmonary Fibrosis; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Yu Cao, Doctor

  The Affiliated Hospital of Qingdao University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2024
• First Posted: September 19, 2024
• Study Start: August 25, 2023
• Primary Completion: September 5, 2023
• Study Completion: September 14, 2023
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)