Angina caused by coronary artery disease
Conditions
Interventions
TRR group:Nitroglycerin subelingual tablets were administered in the order of T-R-R or reference reagent
Reference preparation - Test preparation - Reference preparation (RTR group):The reference reagent or the test preparation of nitroglycerin subolingua tablets was given in the R-T-R administration seq
RRT group:The reference reagent or the test preparation of nitroglycerin suboglossum tablets was given in the R-R-T administration sequence
Sponsors
Taizhou Hospital of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Male and female over 18 years of age (including 18 years of age), with an appropriate sex ratio; 2.Male weight >=50.0kg, female weight >=45.0kg; Body mass index (BMI) in the range of 19.0~26.0kg/m^2 (including the critical value); 3.Health status: Physical examination, vital signs examination, laboratory examination (blood routine, urine routine, blood biochemistry, coagulation four items, eight items before transfusion), 12-lead electrocardiogram examination results are normal or abnormal without clinical significance; 4.Oral examination results are normal or do not affect the absorption of sublingual drugs in the oral cavity; 5.No pregnancy plan, no voluntary use of effective contraception (Appendix 2) and no sperm or egg donation plan between 2 weeks before the trial and 3 months after the last dosing; 6.Be able to communicate well with researchers and understand and commit to the requirements of the study.
Exclusion criteria
Exclusion criteria: 1.People who are known to be allergic to any drug, biological agent, food or pollen, or have a history of specific allergic reactions (such as atopic dermatitis, asthma, rubella, eczematous dermatitis) or are severely allergic, or are known to be allergic to nitroglycerin and its excipiants (lactose), and are judged by the investigator to be clinically significant; 2.Have a history of recurrent oral mucosal disease (such as oral ulcer, herpes simplex stomatitis, oral leukoplakia, lichen planus, gingivitis, etc.) or oral mucosal disease, dental surgery, or oral surgical wound within 14 days before the test and did not heal; 3.Patients with a history of vomiting, diarrhea, or any physiological condition that interferes with the test results within 7 days prior to the test; 4.Chronic mental illness or mental abnormality; 5.Patients with severe anemia or elevated intracranial pressure; 6.Often appear postural hypotension or headache, dizziness symptoms; 7.People with a history of hereditary galactose intolerance, lactase deficiency, or glucose-galactose malabsorption; 8.Patients who had a history of myocardial infarction, shock, or life-threatening arrhythmia within 6 months prior to screening; Patients with heart failure or coronary unstable angina; 9.History of any chronic or serious medical condition of the circulatory system, digestive system, urinary system, respiratory system, nervous system, immune system, endocrine system, mental or metabolic disorders, or any other medical condition that may interfere with the test results; 10.Patients who have undergone major surgery within 3 months prior to administration, or who plan to undergo surgery during the trial period, and who have undergone surgery that affects the pharmacokinetic properties of the drug; 11.Patients who cannot tolerate venipunction, or have a history of fainting needles and fainting blood; 12.A history of drug abuse in the year preceding screening, or use of drugs in the six months preceding screening, including repeated, heavy use of narcotic drugs and psychotropic substances for non-medical purposes, Or urine addictive drugs morphine, methamphetamine (methamphetamine), ketamine, dimethylene dioxyamphetamine (ecstasy), tetrahydrocannabinol (cannabis) screening test any one or more positive results; 13.Participants who have participated or are participating in other drug clinical trials within 3 months prior to screening; 14.People who donated blood within 3 months prior to screening, including component blood or large blood loss (>=400mL), received blood transfusion or used blood products; Or intends to donate blood (including blood components) during or within 3 months after the end of the trial; 15.Women in pregnancy, breastfeeding, or abnormal blood pregnancy test results; 16.Use of any drug that inhibits or induces liver metabolism of drugs (e.g., rifampicin, hypericum perforatum, phenytoin, carbamazepine, phenobarbital and dexamethasone, neomycin) within 28 days prior to screening; Phosphodiesterase-5 (PDE-5) inhibitors: such as sildenafil citrate, tadalafil, Vardenafil hydrochloride; Soluble guanylate cyclase activator Leociguide, etc.); 17.People who have used any prescription, over-the-counter, herbal and vitamin medicines in the 14 days prior to screening; 18.Those who received the vaccine within 7 days prior to administration, or who plan to receive the vaccine during the trial; 19.Smoking more than 5 cigarettes per day in the 3 months prior to screening, or
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The peak concentration Cmax, the area under the drug concentration-time curve AUC0-T, and the area under the curve from administration to extrapolation to infinity time AUC0; | — |
Secondary
| Measure | Time frame |
|---|---|
| Seated vital signs, physical examination;Blood routine, blood biochemistry, urine routine, blood coagulation, blood pregnancy test (female), 12-lead electrocardiogram;The time to reach the peak concentration Tmax, the elimination rate constant ?z of the blood concentration of the terminal phase, the elimination half-life of the terminal terminal t1/2, and the perce; | — |
Countries
China
Contacts
Public ContactXu Luwei
Taizhou Hospital of Traditional Chinese Medicine
Outcome results
None listed