Comparative Pharmacokinetic Study of Pirfenidone Modified-Release Tablets in Healthy Subjects Und… (NCT06569381) | Clinical Trial Compass
CompletedPhase 1
Comparative Pharmacokinetic Study of Pirfenidone Modified-Release Tablets in Healthy Subjects Under Fasting and Fed Conditions
China18 participantsStarted 2024-09-18
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Peak concentration at each treatment period (Cmax,tp)
Timeframe: 1 month
2
Area under the curve from time zero to the time of the last quantifiable plasma concentration of the period (AUC0-last)
Timeframe: 1 month
3
Area under the curve from time zero to infinity (AUC0-inf)
. 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;