The Study of Pharmacokinetics and Pharmacodynamics of Huperzine A Injection in Healthy Chinese Subjects
- Conditions
- Healthy Subjects
- Registration Number
- NCT06570655
- Lead Sponsor
- Wanbangde Pharmaceutical Group Co., LTD
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- All
- Target Recruitment
- 12
Inclusion Criteria:<br><br> 1. The subject voluntarily confirms his or her willingness to participate in a<br> particular trial and signed the written informed consent, after having been informed<br> of all aspects of the trial that are relevant to the subject's decision to<br> participate.They were fully aware of the adverse reactions and voluntarily signed<br> the written informed consent.<br><br> 2. The subjects were able to communicate well with the investigators and complete the<br> trial in accordance with the protocol;<br><br> 3. Gender: Chinese male or female;<br><br> 4. Age: 18-45 years old (including boundary value);<br><br> 5. Body mass index (BMI) 19.0-26.0 kg/m2 [BMI = weight/height 2 (kg/m2)] (including<br> boundary values), body weight =50kg for men and =45kg for women.<br><br>Exclusion Criteria:<br><br> 1. Allergic history to huperzine A or any of its components; Patients with a history of<br> allergy to two or more drugs or foods;<br><br> 2. patients who have the following clinically significant diseases at present,<br> including but not limited to diseases of the respiratory system, circulatory system,<br> digestive system, blood system, endocrine system, immune system, skin system, mental<br> nervous system, ENT and other related diseases;<br><br> 3. existing or suspected existing epilepsy, angina pectoris, bronchial asthma,<br> mechanical intestinal obstruction, renal insufficiency, urinary obstruction;<br><br> 4. underwent major surgical procedures within 6 months before screening or planned to<br> undergo surgical procedures during the trial;<br><br> 5. if the vital signs, physical examination, electrocardiogram and laboratory findings<br> are clinically significant;<br><br> 6. patients with a history of hepatitis B, hepatitis C, AIDS, syphilis and/or<br> clinically significant abnormalities in one or more of the four hemodialysis tests;<br><br> 7. those who had lost blood within 3 months before screening (except physiological<br> blood loss in women) or donated blood =200mL or donated blood components (such as<br> plasma, platelets, peripheral blood stem cells, etc.) within 3 months;<br><br> 8. use of any drugs that alter liver enzyme activity within 30 days before screening<br> (e.g., inductors-barbiturates, carbamazepine, phenytoin, dexamethasone, etc.;<br> "Inhibitors - SSRI antidepressants, ciprofloxacin, diltiazem, macrolides,<br> metronidazole, ketoconazole, verapamil.<br><br> Rice, fluoroquinolones);<br><br> 9. patients who had used any drugs (including prescription drugs, over-the-counter<br> drugs, Chinese herbal medicine) and health products within 14 days before screening,<br> except topical drugs and eye drops;<br><br> 10. vaccinated within 1 month before screening or during the planned trial period and<br> within 1 month after the end of the trial;<br><br> 11. participants who participated in a clinical trial and took a drug within 3 months<br> before screening;<br><br> 12. had a history of drug abuse within 5 years, and/or used drugs within 3 months before<br> screening, and/or had a history of drug dependence, including herbal medicine, or<br> screened positive for drug abuse;<br><br> 13. smokers or those who did not agree to avoid using any tobacco products 48 hours<br> before administration and during hospitalization, or who screened positive for<br> nicotine at the first admission;<br><br> 14. Regular drinkers in the preceding 6 months, defined as consuming more than 14 units<br> of alcohol per week (1 unit =360mL of 5% beer or 45mL of 40% spirits or 150mL of 12%<br> wine), Or did not agree to stop alcohol intake 48 hours before administration and<br> during hospitalization, or had a positive breath alcohol test at first admission;<br><br> 15. subjects who consumed excessive amounts of tea, coffee and/or caffeinated beverages<br> (> 8 cups, 1 cup =250mL) per day before screening or disagreed with the<br> prohibition of tea, coffee and/or caffeinated beverages 48 hours before drug<br> administration and during hospitalization Or caffeinated foods, grapefruit<br> (grapefruit) and/or grapefruit juice (grapefruit juice), and/or products containing<br> poppy;<br><br> 16. have a fertility plan (including sperm and egg donation plans) and/or do not agree<br> to use an effective contraceptive method (non-drug during the trial) from the time<br> of signing the informed consent until 3 months after the last dose of medication.<br><br> Of;<br><br> 17. difficulty in venous blood collection (unable to tolerate venipuncture, with a<br> history of dizzy with needles and blood, poor vascular conditions, etc.);<br><br> 18. subjects may not be able to complete the study for other reasons or should not be<br> included according to the investigator's opinion.<br><br> In addition to the above requirements, female subjects who meet the following<br> conditions should also be excluded:<br><br> 19. pregnant or lactating women or those with a positive pregnancy test;<br><br> 20. who used oral contraceptives within 30 days before screening;<br><br> 21. using long-acting estrogen and/or progestin injections and/or implants within 6<br> months before screening;<br><br> 22. had unprotected sex with a partner within 14 days before screening.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pharmacokinetics (PK): Maximum blood concentration of Huperzine A(Cmax);PK: Area under the Huperzine A blood concentration-time curve from 0min to the time of last concentration(AUC0-t);PK:Area under the Huperzine A blood concentration-time curve from 0min to the infinity time (AUC0-8)
- Secondary Outcome Measures
Name Time Method PD: maximum efficacy(Emax);PD: Area under the efficacy curve(AUEC);PD: Time to reach maximum efficacy(Tmax);PK: Time to peak maximum concentration of the Huperzine A(Tmax);PK: half life of Huperzine A(t1/2);PK: ?z;PK: Area under the curve(AUC_%Extrap);PK: Clearance(CL);PK:Apparent volume of distribution(Vd);PK:Bioavailability(F);Urine excretion of Huperzine A.(UE);Cumulative urinary excretion of Huperzine A(CUE);Urine excretion rate(UER);Cumulative urinary excretion rate(CUER);Faeces excretion(FE);Faeces excretion rate(FER);Metabolites of Huperzine A;Number of participants with adverse events (AEs) or serious adverse events (SAEs) as assessed by NCI-CTCAE v5.0.