Status:
COMPLETED
Comparative Pharmacokinetic Study of Pirfenidone Modified-Release Tablets and Pirfenidone Tablets in Healthy Subjects Under Fed Conditions
Lead Sponsor:
Overseas Pharmaceuticals, Ltd.
Conditions:
Idiopathic Pulmonary Fibrosis
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 C...
Detailed Description
It is designed to be a single-center, randomized, open-label, two-period, double-crossover trial. All subjects must sign an informed consent form (ICF) prior to participation in the trial. Twenty-four...
Eligibility Criteria
Inclusion
- 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
- 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;
- Subjects positive for HBsAg, HCV-Ab, anti-HIV or primary syphilis screening;
- Subjects positive for drug screening or with a history of drug abuse within the past five years or using drugs 3 months before the trial;
- Subjects with underlying medical, psychiatric, psychological or other discomfort conditions, poor compliance, or who, as judged by the investigator, are not suitable for the study.
Key Trial Info
Start Date :
August 25 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 14 2023
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT06589921
Start Date
August 25 2023
End Date
September 14 2023
Last Update
September 19 2024
Active Locations (1)
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1
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, China, 266000