Gout
Conditions
Interventions
20mg dose group (A- Wash period -B):The subjects were given a single dose of 20mg of Teninade tablets on an empty stomach. After a 5-day washing period, 20mg of Teninade tablets were given a single do
20mg dose group (B- Wash period -A):After the subjects were given a single dose of 20mg of Teninade tablets after a meal, they were given a washing period of 5 days and a single dose of 20mg of Tenina
80mg dose group (A- Wash period -B):After a single administration of 80mg of Teninade tablets on an empty stomach, the subjects were given a washing period of 5 days, followed by a single administrati
80mg dose group (B- Wash period -A):After the subjects were given 80mg of Teninade tablets once after a meal, they were given 80mg of Teninade tablets once on an empty stomach for a 5-day wash period
Sponsors
The First Affiliated Hospital of Tianjin University of Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: 1.Healthy volunteers aged 18 to 50 years (inclusive) at the time of signing the informed consent form, both males and females; 2.Body weight >=50 kg for males and >=45 kg for females. Body mass index (BMI) within the range of 19.0–26.0 kg/m² (inclusive). (BMI = weight (kg)/height² (m²)); 3.Female volunteers of childbearing potential with negative pregnancy test results (urine or blood); 4.Female volunteers must agree to use reliable contraceptive measures from the date of signing the informed consent form until 3 months after the trial completion; male volunteers must agree to ensure their partners use reliable contraceptive measures during the same period; 5.Voluntary participation in the trial with signed informed consent and willingness to comply with all trial protocol requirements.
Exclusion criteria
Exclusion criteria: 1.Women who are pregnant or breastfeeding; 2.Subjects planning to conceive within the next 6 months; 3.Participation in other investigational drug trials within 3 months prior to screening, or planned participation during this study period; 4.Positive SARS-CoV-2 nucleic acid test result at screening; 5.Subjects with significant medical history of central nervous system, cardiovascular, renal, hepatic, gastrointestinal (e.g., diarrhea, vomiting, inflammatory bowel disease, hemorrhoids, acute gastroenteritis, peptic ulcer, chronic malabsorption disorders, etc.), respiratory, or metabolic disorders; particularly any conditions increasing bleeding risk within 3 months; psychiatric history; or dysphagia; 6.History of allergies including specific allergies (asthma, urticaria, eczema, etc.), known/suspected hypersensitivity to the investigational product, or history of food/pollen/other allergies; 7.Blood donation (>=400 mL) or significant blood loss within 3 months prior to screening, or receipt of blood transfusion/products; 8.History of needle or blood phobia; 9.Clinically significant abnormalities in physical examination, abdominal ultrasound (liver/gallbladder/spleen/pancreas/kidneys), chest X-ray, echocardiography, or ECG at screening; 10.Serum uric acid (sUA) >420 µmol/L at screening, or history of hyperuricemia and/or gout; 11.Estimated glomerular filtration rate (eGFR) =140 mmHg; diastolic BP =90 mmHg; pulse =100 bpm; or orthostatic hypotension; 13.Laboratory safety parameters outside normal ranges with clinical significance per investigator judgment; 14.Positive viral serology (HBsAg, Anti-HCV, HIV antibody, or TP-CLIA); 15.Subjects with positive urine drug screening results or a history of drug abuse within the past five years; 16.History of smoking (>5 cigarettes/day in past month) or excessive alcohol use (>=5 units/week or >=1 unit/day; 1 unit=25 mL spirits/100 mL wine/285 mL beer), unwilling to abstain during the study; 17.Use of prescription drugs, OTC medications, vitamins, or herbal products within 14 days prior to screening; 18.Consumption of chocolate, caffeine-, or xanthine-containing foods/beverages within 48 hours pre-admission; 19.Positive alcohol breath test prior to admission to the Phase I clinical research unit; 20.Previous exposure to the investigational product in this study; 21.Any other conditions deemed unsuitable by investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Concentration of Tininurad and Its Metabolites in Plasma;Adverse Events;Pharmacokinetic (PK) Parameters of the Drug in Blood; | — |
Secondary
| Measure | Time frame |
|---|---|
| Symptoms;Serum Uric Acid (sUA);Laboratory Tests;Physical Examinations;12-Lead ECG;Vital Signs;Echocardiography;Urinary System Ultrasound; | — |
Countries
China
Contacts
Public ContactHu Siyuan
The First Affiliated Hospital of Tianjin University of Chinese Medicine
Outcome results
None listed