Comparative Pharmacokinetic Study of Pirfenidone Modified-Release Tablets in Healthy Subjects Under Fasting and Fed Conditions
- Conditions
- Idiopathic Pulmonary Fibrosis
- Registration Number
- NCT06569381
- Lead Sponsor
- Overseas Pharmaceuticals, Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not yet recruiting
- Sex
- All
- Target Recruitment
- 18
Inclusion Criteria:<br><br> 1. Healthy male and female subjects over the age of 18 years (including those aged 18<br> years), with an appropriate sex ratio;<br><br> 2. Male subjects with a body weight = 50.0 kg, and female subjects with a body weight =<br> 45.0 kg; BMI (BMI = body weight (kg)/[height (m)]2) within the range of 19-26.0<br> kg/m2 (including the critical value);<br><br> 3. Subjects with good health conditions, no clinically significant medical history in<br> respiratory system, circulatory system, digestive system, urinary system, blood<br> system, endocrine system, immune system, nervous system, and mental system;<br><br> 4. Subjects (including partners) who have no plans of pregnancy and voluntarily take<br> appropriate contraceptive measures from the date of signing the informed consent (14<br> days before signing the informed consent for female subjects) to 6 months after the<br> end of the study;<br><br> 5. Subjects who are able to communicate well with the investigator and understand and<br> adhere to the study requirements. Subjects who fully understand the objective,<br> nature, method and possible ARs of the trial, voluntarily act as subjects, and sign<br> the ICF before any study procedures are started;<br><br>Exclusion Criteria:<br><br> 1. Patients with an allergic history to the study drug or its excipients (such as<br> lactose), or an allergic history to drug, food , pollen or a specific allergic<br> history (asthma, allergic rhinitis, eczema);<br><br> 2. Patients with a history of photosensitivity and existing skin irritation symptoms<br> such as rash and pruritus;<br><br> 3. Subjects who have special dietary requirements and cannot accept a unified diet;<br><br> 4. Subjects with a history of dysphagia or any gastrointestinal disorder affecting drug<br> absorption;<br><br> 5. Subjects who cannot tolerate venipuncture and have a history of fear of needles and<br> hemophobia;<br><br> 6. Subjects with clinically significant hematological, endocrine, cardiovascular,<br> hepatic, renal and pulmonary disorders that may affect drug absorption,<br> distribution, metabolism and excretion;<br><br> 7. Subjects with a surgical history or taking the study drug or participating in other<br> drug clinical trials within 3 months prior to the study;<br><br> 8. Subjects with blood donation or massive blood loss (> 450 mL) within 3 months before<br> the study;<br><br> 9. Subjects taking special diet (including pitaya or grapefruit and products containing<br> grapefruit ingredients) or having strenuous exercise within 7 days before taking the<br> study drug, or having other factors affecting drug absorption, distribution,<br> metabolism and excretion;<br><br> 10. Subjects administered with any prescription drugs, over-the-counter, herbal, or<br> health products within 14 days prior to taking the study drug;<br><br> 11. Regular drinkers within 6 months prior to the study, i.e., drinking more than 14<br> units of alcohol per week (1 unit = 360 mL of beer or 45 mL of spirit containing 40%<br> alcohol or 150 mL of wine);<br><br> 12. Subjects smoking more than 5 cigarettes per day in the first 3 months of the study;<br> Or positive results of tobacco test;<br><br> 13. Subjects who have consumed chocolate, any caffeine-containing, or xanthine-rich food<br> or beverage, such as coffee, strong tea, and cola 48 h before taking the study drug;<br><br> 14. Subjects having taken any alcohol-containing products within 48 h before taking the<br> study drug, or having a positive result for alcohol screening;<br><br> 15. Female subjects with positive pregnancy test or lactating during the screening<br> period or during the trial;<br><br> 16. Subjects positive for HBsAg, HCV-Ab, anti-HIV or primary syphilis screening;<br><br> 17. Subjects positive for drug screening or with a history of drug abuse within the past<br> five years or using drugs 3 months before the trial;<br><br> 18. Subjects with underlying medical, psychiatric, psychological or other discomfort<br> conditions, poor compliance, or who, as judged by the investigator, are not suitable<br> for the study.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Peak concentration at each treatment period (Cmax,tp);Area under the curve from time zero to the time of the last quantifiable plasma concentration of the period (AUC0-last);Area under the curve from time zero to infinity (AUC0-inf)
- Secondary Outcome Measures
Name Time Method Time to reach peak concentration of the first dosing (Tmax);apparent volume of distribution(Vd/F);Lag time (tlag);Terminal half-life (T1/2);elimination rate constant(?z);residual area in percentage(AUC_%Extrap);apparent clearance(CL/F)