Pharmacokinetics and Bioequivalence Study in human
Conditions
Interventions
Group A:The first cycle was given finasteride tablets (5 mg/ tablet) manufactured by AIAC International Pharma LLC, the reference preparation, and the second cycle was given finasteride tablets (5 mg/
Group B:The first cycle was given finasteride tablets (5 mg/ tablet) manufactured by Weimin Pharmaceutical Co., LTD., and the second cycle was given finasteride tablets (5 mg/ tablet) manufactured by
Sponsors
Xiangya Bo'ai Rehabilitation Hospital
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Healthy Chinese male subjects aged 18 years or older; 2.Weight >=50 kg, body mass index (BMI) between 19-26 kg / m^2 (BMI = weight (kg) / height 2 (m^2)), including boundary value; 3.The subjects who voluntarily sign the written informed consent before the trial, and have a thorough understanding of the trail content, process and possible adverse reactions; 4.The subjects who are able to communicate well with the investigator and understand and comply with the requirements of this study.
Exclusion criteria
Exclusion criteria: Exclusion criteria for screening period: Patients meet one of the following conditions shall not be selected as subjects: (Consultation + network screening) 1.Subjects who took part in any other clinical trial within 3 months before the study; (Consultation) 2.Patients with gastrointestinal diseases, such as esophageal disease, gastritis, enteritis, irritable bowel syndrome, or gastrointestinal surgery within 3 years prior to the trial, which the investigator considers still clinically significant; (Consultation) 3.History suffering from any clinical disease and still having clinical significance according to the investigator's judgment, such as cardiovascular system, endocrine system, urinary system, nervous system, hematology, immunology,digestive system, metabolic disorders; (Consultation) 4.History suffering from prostate cancer, urethrostenosis, bladder hypotonia, neurogenic disorders and and other diseases similar to benign prostatic hyperplasia (BPH), which will increase the safety risks of the study according to the investigator's judgment; (Consultation) 5.Subjects who have a history of allergy to the drugs or suffers from allergies; (Consultation) 6.Subject who cannot tolerate venipuncture or history suffering from blood phobia or acupuncture syncope; (Consultation) 7.Subjects who have had an surgical procedure ,during 6 month before the study, which could affect drug absorption, distribution, metabolism and excretion according to the investigator's judgment, or had an surgical procedure during 4 weeks before the study, or planned surgery during the study; (Consultation) 8.Subjects who treated with any medicine (including Chinese herbal medicine and vitamin), health products within 14 days before the study; (Consultation) 9.Subjects who treated with any drug that inhibited or induced the metabolism of the liver; (Consultation) 10.Subjects who vaccinated within 30 days before the study, or planned to vaccinate during the study (including attenuated live vaccine and COVID-19 vaccine); (Consultation) 11.Subjects who donated blood or had the blood loss of > 200 mL within 3 months before the study, or planned to donat blood 3 months after the study; (Consultation) 12.Drug abusers or those who used soft drugs (such as cannabis) 3 months before the start of study or those who took hard drugs (such as cocaine, phencyclidine, etc.) 1 years before the start of study; (Consultation) 13.Smokers or those who smoke more than 5 cigarettes per day 3 months before the study, or do not agree to stop smokeing during the study; (Consultation) 14.Drinkers or those who drink frequently 6 months before the study, that is, drinking more than 14 units of alcohol per week (1 unit =360 mL of beer or 45 mL of alcohol with 40% of alcohol or 150 mL of wine), or do not agree to stop drinking during the study; (Consultation) 15.Subjects drink excessive amounts of tea, coffee and / or beverages with caffeine or xanthine (8 cups or more, 1 cups =250 mL) per day, or do not agree to stop drinking during the study; (Consultation) 16.Subjects who have special requirements for diet, and can not comply with a unified diet; (Consultation) 17.Subjects who suffering from lactose intolerance, galactose intolerance, total lactase deficiency, Glucose-galactose malabsorption; (Consultation) 18.Subjects who had unprotected sex before the 2 weeks of study , male subjects or their spouse (or partner) had a pregnancy or sperm donation plan during and 6 month
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Plasma drug peak concentration;Area under the 0-36 h plasma concentration-time curve;Area under 0 h to infinite blood drug concentration-time curve;Vital signs monitoring;Laboratory examination;Observation and report of clinical symptoms;Adverse events and serious adverse events; | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to peak; | — |
Countries
China
Contacts
Public ContactZhang Bikui
Xiangya Bo'ai Rehabilitation Hospital
Outcome results
None listed