None listed
Conditions
Interventions
T-R group:Screened volunteers were randomized to receive T-R sequential dosing, according to a randomization table, with a single intramuscular injection of either the test formulation [ T, 30 mg (as
manufactured by Nanjing Zhengda Tianqing Pharmaceutical Co. Ltd.), both at a dose of 10 mg (formulated at 20 mg/mL [as ziprasidone], 0.5 mL intramuscularly), administered once per cycle with a washout
R-T group:Screened volunteers were randomized to receive R-T sequential dosing, and according to a randomization table, volunteers received a single intramuscular injection of the reference formulatio
Sponsors
Clinical Trial Center of Third Xiangya Hospital of Central South University
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Chinese subjects aged 18-45 years (including the critical value), no gender limit; 2. The weight of male subjects was >=50.0 kg, the weight of female subjects was >=45.0 kg, and the body mass index (BMI) was between 19 and 26 kg/m^2, including the cut-off value; 3. Subjects voluntarily sign written informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients who have had or are currently suffering from any clinically serious diseases of the circulatory system, endocrine system, nervous system, digestive system, respiratory system, hematologic, immunological, psychiatric and metabolic abnormalities or any other diseases that can interfere with the results of the test, for example, patients with a history of cancer and a history of cardiovascular disease (such as hypertension, bradycardia, tachycardia, arrhythmia, prolonged QT interval, myocardial infarction, heart failure, etc.); 2. Patients who had symptoms such as nausea, dizziness, headache, and drowsiness within 7 days before the first medication, and the researchers considered it inappropriate to participate in the trial; 3. Patients who had surgery within 4 weeks prior to the trial or planned to have surgery during the study period; 4. A history of allergies to drugs, food or other substances; Patients who are allergic to any ingredient in this product and excipients, or have a history of allergy to similar drugs, or have a history of allergic diseases (such as atopic dermatitis, angioneurotic edema, oral and facial edema, urticaria, etc.), and researchers believe that it is still clinically significant; 5. Any drug that has a pharmacodynamic effect of prolonging the QT interval, or a drug that is contraindicated in the prescribing information for patients with prolonging the QTc interval, or a drug with a black box warning for caution in patients with prolonging the QTc interval within 30 days before the trial; 6. Patients who have used any drugs (including vitamins and Chinese herbs) within 14 days before the test; 7. Patients who have taken or participated in any clinical trial drug within 3 months before the trial; 8. Patients who donate blood or blood loss greater than 200 mL within 3 months before the trial, or who plan to donate blood or blood components during the study period or within 3 months after the study ends; 9. The patient (or his or her partner) has a pregnancy plan, sperm and egg donation plan from the trial period to 3 months after the trial, or cannot use one or more non-drug contraceptive methods (such as total abstinence, Icontraceptive ring, partner ligation, etc.) during the trial period; 10. Pregnant or lactating patients, or female patients with positive pregnancy test results; 11. Those who have special requirements for diet and cannot comply with a unified diet; 12. Smokers or those who smoked more than 5 cigarettes per day in the 3 months before the trial, or those who could not stop using any tobacco products during the trial; 13. Alcoholics or regular drinkers in the six months prior to the trial, i.e. those who drink more than 14 units of alcohol per week (1 unit =360 mL beer or 45 mL spirits with 40% alcohol or 150 mL wine), or who cannot stop using any alcoholic products during the trial period; 14. Excessive consumption of tea, coffee and/or caffeinated beverages (more than 8 cups, 1 cup =250 mL) per day; 15. Drug abusers or those who have used soft drugs (e.g., cannabis) in the 3 months prior to the trial or hard drugs (e.g., cocaine, PCP, etc.) in the 1 year prior to the trial; 16. Patients who cannot tolerate venous puncture or have a history of fainting blood or fainting needles; 17. Patients with expected difficulty in venipuncture or blood collection; 18. Patients with abnormal vital signs during screening (systolic blood pressure 140 mmHg, diastolic blood pressure <60
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Peak concentration, Cmax;Area under the plasma concentration - time curve, AUC0-t;Area under the curve extrapolated from zero to infinity, AUC0-8; | — |
Secondary
| Measure | Time frame |
|---|---|
| Peak concentration time, Tmax;Terminal elimination half-life, T1/2z;End-phase elimination rate constant, ?z; | — |
Countries
China
Contacts
Public ContactYang Guoping
Clinical Trial Center of the Third Xiangya Hospital of Central South University
Outcome results
None listed