Pharmacokinetics and Bioequivalence Study in human
Conditions
Interventions
Experimental group1:A single oral dose of the test reference preparation (T) on an empty stomach in the morning of cycle I, and cross-administered R in cycle II according to a random table
Experimental group2:A single oral dose of the test reference preparation (T) on an empty stomach in the morning of cycle I, and cross-administered R in cycle II according to a random table
Sponsors
Xiangya Boai Rehabilitation Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Chinese healthy subjects over 18 years old (including 18 years old), both male and female; 2. Male weight >= 50 kg; female weight >= 45 kg; body mass index in the range of 19~26 kg/m2 (including the critical value) (body mass index (BMI) = weight (kg) / height 2 (m2)); 3. Sign the informed consent form before the test, and fully understand the test content, process and possible adverse reactions; 4. The subjects can communicate well with the researcher, and understand and comply with the requirements of this research.
Exclusion criteria
Exclusion criteria: 1. Those who participated in any clinical trial within 3 months before the trial; 2. Those with orthostatic hypotension in the past; 3. Those who have a medical history of the motor system, digestive system, respiratory system, urinary system, reproductive system, endocrine system, immune system, nervous system and circulatory system in the past and the researchers believe that there is still clinical significance; 4. Those who are allergic to prazosin, other quinolines or any other ingredients in this product, or have allergic constitution; 5. Driving, aerial work and machinery operators are required during the test; 6. Those who are intolerant to venipuncture or have a history of fainting blood or acupuncture; 7. Those who have undergone surgery that, as judged by the investigator, will affect the absorption, distribution, metabolism, and excretion of drugs within 6 months before the trial; or who have undergone any surgery within 4 weeks before the trial; or those who plan to undergo surgery during the study; 8. Those who have used any drugs (including Chinese herbal medicines, vitamins, etc.), health products, etc. within 14 days before the test; 9. Those who have used any drugs that inhibit or induce liver metabolism of drugs within 30 days before the test; 10. Those who have been vaccinated within 14 days before the trial, or who plan to be vaccinated during the trial (including live attenuated vaccines and new crown vaccines); 11. Those who donated blood or lost a large amount of blood (>200 mL, except women's menstrual period) within 3 months before the trial, or those who plan to donate blood during the trial or within 3 months after the end of the trial; 12. Drug abusers or those who have used soft drugs (such as marijuana) or hard drugs (such as cocaine, phencyclidine, etc.) within 1 year before the test; 13. Smokers or those who smoked more than 5 cigarettes per day within 3 months before the trial, or those who do not agree to stop using any tobacco products during the trial; 14. Alcoholics or frequent drinkers within 6 months prior to the trial, i.e. drinking more than 14 units of alcohol per week (1 unit = 360 mL of beer or 45 mL of 40% alcohol or 150 mL of wine); or disagree Those who stopped drinking alcohol or any alcoholic products during the trial; 15. Those who drink too much tea, coffee and/or caffeinated beverages (more than 8 cups, 1 cup = 250 mL) every day, or those who do not agree to stop drinking tea, coffee and/or caffeinated beverages during the trial; 16. Those who have special requirements for diet and cannot comply with the unified diet; 17. Unprotected sexual behavior occurred within 2 weeks before the trial, and the subject or his spouse (or his partner) had a pregnancy plan, sperm donation and egg donation plan during the trial period to 3 months after the end of the trial, or did not agree to the Those who took one or more non-drug contraceptive measures (such as complete abstinence, contraceptive ring, partner sterilization, etc.) during the trial; 18. Women who are pregnant or breastfeeding; 19. Patients with abnormal electrocardiogram, laboratory examination and vital signs and clinical significance; 20. Subjects with poor compliance or may be unable to complete the study for other reasons or have other reasons judged by the investigator to be unsuitable to participate in the trial. Exclusion criteria for each period of stay: One of the following conditions should also be excl
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Peak plasma drug concentration;Area under the drug concentration-time curve from 0 h to th h;Area under the plasma concentration-time curve from 0 h to infinity; | — |
Secondary
| Measure | Time frame |
|---|---|
| peak time; | — |
Countries
China
Contacts
Public ContactZhang Bikui
Outcome results
None listed