angina
Conditions
Interventions
Fasting Group ?(T-R-T-R):Subjects fasted for at least 10 hours prior to each cycle of administration, took the subject formulation or reference formulation sublingually on an empty stomach on the morn
Fasting Group ? (R-T-R-T):Subjects fasted for at least 10 hours prior to each cycle of dosing and took the subject formulation or reference formulation sublingually on an empty stomach on the morning
Sponsors
Hangzhou Red Cross Hospital
Eligibility
Sex/Gender
All
Age
23 Years to 35 Years
Inclusion criteria
Inclusion criteria: Subjects must meet all of the following criteria for enrollment: 1) Age = 18 years, both male and female; 2) Male subjects weighing =50.0 kg and female subjects weighing =45.0 kg with a body mass index (BMI) between 19 and 26 kg/m2 (including borderline values); 3) Subjects voluntarily signed a written informed consent form.
Exclusion criteria
Exclusion criteria: Subjects meeting one or more of the following criteria will be excluded: 1) (Inquire) Those who have a history or are currently suffering from any clinically serious disease of the circulatory system, endocrine system, nervous system, digestive system, respiratory system, hematology, immunology, psychiatry, and metabolic abnormalities, or any other disease capable of interfering with the results of the test (e.g., known myocardial infarction, anemia, elevated intracranial pressure, hypotension, etc.); 2) (Inquire) Those who have a history of recurrent oral mucosal disease (e.g., oral ulcers, herpes simplex stomatitis, oral mucosal leukoplakia, lichen planus, gingivitis, etc.) or those who have had oral mucosal disease, dental surgery, or oral surgical wounds that have not healed within the 14 days prior to the test; 3) Physical examination with oral mucosal abnormalities confirmed by the Investigator; 4) (Inquire) A history of drug, food or other substance allergy, or hypersensitivity to any of the ingredients in this product; 5) (Inquire) who has undergone surgery within 28 days prior to the first dose of study drug or who is scheduled to undergo surgery (e.g., invasive dental procedures) during the trial period; 6) (Inquire) Anyone who has used any medications or supplements (including herbal remedies) within 14 days prior to the first dose of study drug; 7) (Inquire) Use of any drug that inhibits or induces hepatic metabolism of a drug within 30 days prior to the first dose of study drug (e.g., inducers-barbiturates, carbamazepine, phenytoin sodium, rifampicin, etc.; inhibitors-SSRI antidepressants, cimetidine, cyclosporine, macrolides, verapamil, quinolones, Pyrrole antifungals, HIV protease inhibitors, etc.); 8) (Inquire) Use of any clinical trial drug or enrollment in any drug/medical device clinical trial within 3 months prior to the first dose of study drug; 9) (Inquire) Blood donation within 3 months prior to the first dose of study drug, or blood loss of more than 400 mL within 3 months prior to the first dose of study drug; 10) (Inquire) Individuals who cannot tolerate venipuncture and/or have a history of blood or needle sickness; 11) (Inquire) 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; 12) (Inquire) Individuals (females) who have had unprotected sex within 14 days prior to the first dose of study drug, or females who are pregnant or breastfeeding; 13) (Inquire) who are unable to use one or more non-pharmacological contraceptive methods during the trial period; 14) (Inquire) Persons with special dietary requirements, inability to follow a standardized diet, or dysphagia; 15) (Inquire) who have consumed excessive amounts of tea, coffee, or caffeinated beverages (more than 8 cups, 1 cup = 250mL) per day within 3 months prior to the first dose of study drug; 16) (Inquire) Anyone who has consumed or plans 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 the first dose of study drug; 17) (Inquire) Persons who have ingested or plan to ingest grapefruit or grapefruit-related citrus fruits (e.g., limes, grapefruit), poppies, papayas, pomegranates, or products of the above fruits within 14 days prior to the first dose
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax;AUC0-8;AUC0-t; | — |
Secondary
| Measure | Time frame |
|---|---|
| Tmax;?z;t1/2;CL/F;Vd/F; | — |
Countries
China
Contacts
Public ContactYing Wang
Hangzhou Red Cross Hospital
Outcome results
None listed