None listed
Conditions
Interventions
Group I:After meals, take a single oral dose of the test preparation (T, 50 mg), and after a 7-day washout period, take a single oral dose of the reference preparation (R, 50 mg).
Group II:After meals, take a single oral administration of the reference formulation (R, 50 mg), and after a 7-day washout period, take a single oral administration of the test formulation (T, 50 mg).
Sponsors
Yuebei People’s Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Healthy male or female = 18 years old; 2.Male subjects weighting >50.0 kg and female subjects weighting >45.0 kg with a body mass index (BMI) of 19-26 kg/m2 (including borderline values). 3.Subjects voluntarily signed a written informed consent form;
Exclusion criteria
Exclusion criteria: 1.(INQUIRY) Previous or current treatment for any clinically serious disease of the circulatory system, endocrine system, nervous system, digestive system, respiratory system, hematology, immunology, psychiatry, or metabolic abnormalities, or any other disease that interferes with the results of the test (e.g., known gastrointestinal perforations, gastrointestinal fistulas, esophageal disorders, gastritis, gastrointestinal ulcers, enteritis, GERD, pancreatitis, active gastrointestinal bleeding, etc.). bleeding, etc.); 2.(INQUIRY) History of allergy to 3 or more substances, or allergy to any of the ingredients in this product; 3.(INQUIRY) Those who have undergone surgery within 28 days prior to the first dose of study drug or who plan to have surgery during the trial period; 4.(INQUIRY) Used any medication or nutraceuticals (including herbal remedies) within 14 days prior to first dose of study drug. 5.(INQUIRY) Used any clinical trial drug or enrolled in any drug/medical device clinical trial within 3 months prior to first dose of study drug. 6.(INQUIRY) Blood donation within 3 months prior to the first dose of study drug or blood loss of more than 400mL within 3 months prior to the first dose of study drug. 7.(INQUIRY) Cannot tolerate venipuncture and/or have a history of blood or needle sickness. 8.(INQUIRY) Those who have used oral contraceptives within 30 days prior to the first dose of study drug or who have used long-acting estrogen or progestin injections or implants within 6 months prior to the first dose of study drug; 9.(INQUIRY) Those who have had unprotected sex within 14 days prior to the first dose of study drug (females) or who are expectant or breastfeeding; 10.(INQUIRY) Those who have had unprotected sex within 14 days prior to the first dose of study drug; 11.(INQUIRY) Those who are unable to use 1 or more non-pharmacological contraceptives during the trial period; 12.(INQUIRY) Those who have special dietary requirements, who are unable to comply with a uniform diet or who have difficulty swallowing, or who are lactose intolerant (e.g., dyspepsia of lactose occurs after consumption of cow's milk or milk preparations, with abdominal distension, bowel sounds, acute abdominal pain, diarrhea, etc.); 13.(INQUIRY) Those who have had unprotected sex within 14 days before taking the study drug for the first time (female), or are pregnant or breastfeeding. 14.(INQUIRY) Those who consumed excessive amounts of tea, coffee, or caffeine-containing beverages (more than 8 cups, 1 cup = 250mL) per day within 3 months prior to the first dose of study drug; 15.(INQUIRY) Those who have consumed or plan to consume any caffeine-containing foods or beverages (e.g., coffee, strong tea, chocolate, etc.) or xanthine-rich foods (e.g., sardines, animal liver, etc.) or beverages in the 48 hours prior to taking the first dose of study drug; 16.(INQUIRY)Those who have ingested or plan to ingest grapefruit or grapefruit-related citrus fruits (e.g., sour, grapefruit), poppies, papaya, pomegranate, dragon fruit, or products of the above fruits within 14 days prior to the first dose of study drug; 17.(INQUIRY) Smokers or smokers who smoked more than 5 cigarettes per day in the 3 months prior to the first dose of study drug; 18.(INQUIRY) Alcoholics or those who consumed alcohol on a regular basis, i.e., more than 14 units of alcohol per week (1 unit ~ 200 mL of beer 5% alcohol by volume, or 25 mL of spirits 40% alcohol by volume, or 85
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax;AUC0-t;AUC0-8;AUC0-t;AUC0-8; | — |
Countries
China
Contacts
Public ContactWenmao Fan
Yuebei People’s Hospital
Outcome results
None listed