Comparative Pharmacokinetic(PK) Study of Pirfenidone Modified-Release Tablets and Pirfenidone Tab… (NCT06588517) | Clinical Trial Compass
CompletedPhase 1
Comparative Pharmacokinetic(PK) Study of Pirfenidone Modified-Release Tablets and Pirfenidone Tablets in Healthy Subjects Under Fed Conditions
China12 participantsStarted 2024-04-08
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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;
Exclusion criteria
✕. 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);
What they're measuring
1
Area under the curve from time zero to the time of the last quantifiable plasma concentration of the period (AUC0-last)
Timeframe: 1 month
2
Area under the curve from time zero to infinity (AUC0-inf)
✕. 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;