Gout with hyperuricemia.
Conditions
Interventions
Group B:In a fasting state, first take the test formulation (Dutasteride tablets (specification: 2 mg, manufactured by Huayi Pharmaceutical Technology (Anhui) Co., Ltd.)) and then take the reference f
manufactured by Fuji Pharma Co., Ltd.), the washing period is 7 days.
Group A:In a fasting state, first take the reference formulation (Dutasteride tablets (URECE?, 2 mg
manufactured by Fuji Pharmaceutical Co., Ltd.) followed by the test formulation (Dutasteride tablets (2 mg, manufactured by Huayi Pharmaceutical Technology (Anhui) Co., Ltd.), the washing period is 7
Group C:After meals, first take the reference preparation (Dutasteride tablets (URECE?, specification: 2 mg
manufactured by Fuji Pharmaceutical Co., Ltd.) followed by the test preparation (Dutasteride tablets (specification: 2 mg, manufactured by Huayi Pharmaceutical Technology (Anhui) Co., Ltd.), the washi
Group D:After meals, take the test formulation first (Motinorole tablets (specification: 2 mg, produced by Huayi Pharmaceutical Technology (Anhui) Co., Ltd.)) and then take the reference formulation (
produced by Fuji Pharmaceutical Co., Ltd.), the washing period is 7 days.
Sponsors
People's Hospital of Deyang City
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1. Sign the informed consent form before the trial and fully understand the trial content, process, and possible adverse reactions; 2. Be able to complete the study according to the trial protocol requirements; 3. Male and female subjects aged 18–55 years (including 18 and 55 years old); 4. Male subjects with a weight of at least 50 kg. Female subjects with a weight of at least 45 kg. Body Mass Index (BMI) = weight (kg) / height^2 (m^2), with a BMI range of 19.0–26.0 kg/m^2 (inclusive); 5. No history of chronic or severe heart, liver, kidney, gastrointestinal, nervous system, psychiatric disorders, or metabolic abnormalities.
Exclusion criteria
Exclusion criteria: 1. Individuals who smoked an average of >=5 cigarettes per day within 3 months before screening or are unable to abstain from smoking during the trial period; 2. Individuals allergic to two or more substances, or with specific allergy history (e.g., asthma, allergic rhinitis, urticaria, eczema., or allergic to the components of this drug or its analogues; 3. Individuals who regularly consumed alcohol within 6 months before the first dose, defined as drinking more than 14 units of alcohol per week (1 unit = 360 mL of beer with 5% alcohol content, 45 mL of spirits with 40% alcohol content, or 150 mL of wine with 12% alcohol content., or unable to abstain from alcohol from signing the informed consent form until the end of the study, or with a positive alcohol breath test; 4. Individuals who donated blood or experienced significant blood loss (>400 mL. within 3 months before taking the investigational drug, or plan to donate blood from the screening date until 3 months after the last dose; 5. Individuals with dysphagia or any history of gastrointestinal disorders affecting drug absorption; 6. Individuals who used any prescription medication within 14 days before taking the investigational drug; 7. Individuals who used any over-the-counter drugs, herbal medicines, or health products within 7 days before taking the investigational drug; 8. Individuals who consumed special diets (e.g., grapefruit. or engaged in strenuous exercise within 7 days before taking the investigational drug, or had other factors affecting drug absorption, distribution, metabolism, or excretion; 9. Individuals who participated in other drug clinical trials within 3 months before taking the investigational drug; 10. Individuals with unresolved gouty arthritis, arthritis, or limb discomfort within 14 days before screening; 11. Individuals with a creatinine clearance rate <80 mL/min (calculation formula refer to section 8.3.4.; 12. Individuals with a history of liver or kidney impairment; 13. Individuals with a history of kidney stones or urinary tract stones; 14. Individuals who received any vaccine within 1 month before taking the investigational drug or plan to receive vaccination during the trial period; 15. Individuals who used any drugs that inhibit or induce hepatic enzyme activity within 30 days before taking the investigational drug (e.g., inducers—barbiturates, rifampicin, carbamazepine, phenytoin sodium, dexamethasone, etc. inhibitors—SSRI antidepressants, ciprofloxacin, diltiazem, macrolides, metronidazole, ketoconazole, verapamil, fluoroquinolones, etc.. or drugs that interact with dutinoret (e.g., pyrazinamide, salicylate preparations, etc..; 16. Individuals with clinically significant abnormalities as determined by the clinician, including physical examination, vital signs, electrocardiogram, clinical laboratory tests, chest X-ray, or urinary system ultrasound; 17. Individuals positive for hepatitis B virus surface antigen, hepatitis C virus antibody, human immunodeficiency virus antigen and antibody, or syphilis treponema-specific antibody in initial screening; 18. Individuals who consumed excessive tea, coffee, and/or caffeinated beverages (more than 8 cups per day, 1 cup = 250 mL. within 3 months before the first dose, or disagree to abstain from tea, coffee, and/or caffeinated foods, grapefruit (or grapefruit juice., and/or poppy-containing products 48 hours before admission and during hospitalization; 19. Individuals with a positive drug abuse screenin
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetic evaluation indicators (Cmax, AUC0-t, AUC0-8, Tmax, Kel, t1/2, AUC_%Extrap); | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety evaluation indicators (adverse events, serious adverse events, vital signs, physical examination, clinical laboratory tests, electrocardiogram, etc.); | — |
Countries
China
Contacts
Public ContactFan Lianlian
People's Hospital of Deyang City
Outcome results
None listed