Human Pharmacokinetics and Equivalence of Preparations
Conditions
Interventions
Phase II: 40 mg of Tomoxetine Capsules made by Atomotera
Group 1:Phase I: 40 mg of Tomoxetine Capsules made by Atomotera
Phase II: 40 mg of Tomoxetine Capsules by Lilly S.A., Spain
2:Phase I: 40 mg of Tomoxetine Capsules by Lilly S.A., Spain
Sponsors
Xiangya Boai Rehabilitation Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 50 years, male or female; 2. The body weight of male subjects is more than 50 kg, that of female subjects is more than 45 kg, and the body mass index (BMI) is between 19 and 26 kg/m2, including the boundary value; 3. Subjects voluntarily sign written informed consent.
Exclusion criteria
Exclusion criteria: 1. Previously or currently suffering from circulatory system, endocrine system, nervous system, digestive system, respiratory system, hematology, Immunology, psychiatry, metabolic abnormalities and any other diseases that can interfere with the test results are excluded: (1) Postural hypotension prone patients; (2) Angina pectoris; (3) tachycardia; (4) Severe heart disease; (5) Severe congestive heart failure patients; (6) Narrow angle glaucoma. 2. A history of allergies to drugs (e.g. topoxetine), food or other substances; 3. Those who underwent surgery within 4 weeks before the trial or who planned to undergo surgery during the study period; 4. Those who had taken any medicine (including Chinese herbal medicine and health products) within 14 days before the test; 5. Those who had used any drugs to inhibit or induce liver metabolism (e.g. inducers - barbiturates, carbamazepine, phenytoin, glucocorticoids, omeprazole; inhibitors - SSRI antidepressants, cimetidine, diltiazem, macrolides, nitroimidazoles, sedative hypnotics, verapamil, fluoroquinolones, antihistamines) within 30 days before the trial; 6. Those who took any other clinical trial drug or participated in any other clinical trial drug within three months before the trial; 7. Those who participated in blood donation, blood donation or accidental blood loss exceeding 200 mL within 3 months before the test; 8. Women who have unprotected sexual intercourse during pregnancy and lactation, or during and within three months after the trial, and who cannot take one or more contraceptive measures; 9. Those who have special dietary requirements and cannot comply with the unified diet; 10. Drinking excessive amounts of tea, coffee and/or caffeine or xanthine-rich beverages (more than 8 cups, 1 cup = 250 mL) daily; 11. Those who had eaten grapefruit juice, grape juice, cabbage vegetables, pitaya fruit or food or beverage prepared by them within 2 days before the experiment; 12. Smokers or those who smoked more than 5 cigarettes a day three months before the trial; 13. Alcoholics or regular drinkers within 6 months before the trial, i.e. those who drank more than 14 units of alcohol per week (1 unit = 360 mL beer or 40% spirits or 150 mL wine with 45 mL alcohol); 14. The results of alcohol breathing test were more than 0.0 mg/100 mL. 15. Drug abusers or those who used soft drugs (e.g. cannabis) or hard drugs (e.g. cocaine, phenylcyclohexylpiperidine) three months before the test or one year before the test; 16. Positive results of urine drug screening (morphine, methamphetamine, ketamine, ecstasy and cannabis); 17. Those with abnormal vital signs (systolic blood pressure 140 mmHg, diastolic blood pressure 90 mmHg, pulse 100 bpm) or those with abnormal physical examination, electrocardiogram and laboratory examination having clinical significance (whichever is judged by the researcher).
Countries
China
Contacts
Public ContactZhang Bi Kui
Xiangya Boai Rehabilitation Hospital
Outcome results
None listed