Coronary Heart Disease with Angina Pectoris
Conditions
Interventions
A:Twelve healthy subjects (6 males and 6 females) were enrolled. Each participant first received a single sublingual dose of 5 pills of Suxiao Jiuxin Pill (low sublingual dose). After a 3-day washout
B:Twelve subjects (6 males and 6 females) received a single sublingual dose of 10 pills of Suxiao Jiuxin Pill at a regimen of once daily per person (medium sublingual dose).
C:Six subjects (3 males and 3 females) first received a single sublingual dose of 15 pills of Suxiao Jiuxin Pill, administered once daily per person. After a 3-day washout period, a second dosing tria
D:Six subjects (3 males and 3 females) first received an oral dose of 15 pills of Suxiao Jiuxin Pill, administered once daily per person. After a 3-day washout period, a second dosing trial was conduc
Sponsors
The Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Healthy subjects, with an equal ratio of males and females, aged between 18 and 45 years. 2. All healthy subjects must weigh >=50 kg, with a body mass index (BMI) = weight (kg) / height (m)² falling within the range of 19 to 24 kg/m² (inclusive). 3. All subjects must have passed general physical examinations, laboratory tests, and physicochemical examinations. 4. Healthy subjects must agree to disclose and abstain from specific foods and medications for one week prior to the study. 5. In accordance with Good Clinical Practice (GCP) guidelines, informed consent must be obtained from all volunteers.
Exclusion criteria
Exclusion criteria: 1. Individuals with primary diseases of vital organs (e.g., heart, liver, kidney), history of gastrointestinal disorders, metabolic diseases, or neurological conditions. 2. Patients with mental or physical disabilities. 3. Subjects with clinically significant abnormalities in physical examinations, biochemical tests, routine blood/urine/stool tests, electrocardiogram (ECG), chest X-ray, or ultrasound examinations. 4. History of drug dependence, substance abuse, or alcoholism. 5. Individuals with a history of hypersensitivity or allergic constitution. 6. Use of traditional Chinese medicines or medicated diets within one week prior to the study. 7. Use of any drugs known to inhibit or induce hepatic drug metabolism within 30 days prior to the trial (e.g., inducers—barbiturates, carbamazepine, phenytoin, glucocorticoids, omeprazole; inhibitors—SSRI antidepressants, cimetidine, diltiazem, macrolides, nitroimidazoles, sedative-hypnotics, verapamil, fluoroquinolones, antihistamines). 8. Use of drugs known to cause organ damage within 3 months; any medication use within 2 weeks; or use of investigational drugs within 4 weeks prior to the trial. 9. Pregnant or lactating women, or women of childbearing potential taking contraceptive medications. 10. Abnormal vital signs (systolic blood pressure 140 mmHg; diastolic blood pressure 90 mmHg; heart rate 100 bpm). 11. Regular alcohol consumption within 6 months prior to the trial (exceeding 14 units per week; 1 unit = 360 mL beer, 45 mL of 40% spirits, or 150 mL wine) or positive alcohol breath test; smoking more than 1 cigarette per day within 3 months prior to the trial or positive urine nicotine test. 12. Use of soft drugs (e.g., marijuana) within 3 months or hard drugs (e.g., cocaine, phencyclidine) within one year prior to the trial, or positive urine drug screening. 13. Other factors that may affect drug absorption, distribution, excretion, or metabolism. 14. Blood donation within 3 months prior to the trial. 15. Participation in any clinical trial involving investigational drugs within 3 months prior to the study. 16. Any other conditions deemed by the investigator as unsuitable for enrollment (e.g., frailty).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the blood concentration-time curve from zero to the last measurable concentration time point AUC0-t; Area under the blood concentration-time curve from zero to infinity AUC0-8;Measured peak blood drug concentration Cmax;Cumulative urinary excretion fraction of the drug Fe-U; | — |
Secondary
| Measure | Time frame |
|---|---|
| Tmax;t1/2;Rac;Cum.Ae-U; | — |
Countries
China
Contacts
Public ContactYuhong Huang
The Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
Outcome results
None listed