Pharmacokinetics and Bioequivalence Study in human
Conditions
Interventions
Two groups:Phase I or II giving Haloperidol Tablets (Haloperidol Tablets 5 mg/Tablet) (Vickmans Laboratories Ltd., Hong Kong) versus Phase II or I giving Haloperidol Tablets (Haloperidol 5 mg/Tablet)
Sponsors
Xiangya Boai Rehabilitation Hospital
Eligibility
Sex/Gender
Male
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 55 years old, both males and females with suitable ratio in the study; 2. Body weight of male >=50 kg, body weight of female >=45 kg, and Body Mass Index (BMI) ranged within 19 ~26 kg/m2 including boundary values; 3. All subjects signed the written informed consent.
Exclusion criteria
Exclusion criteria: 1. History or at present suffering from any serious clinical disease, such as circulatory system, endocrine system, nervous system, digestive system, respiratory system, hematology, immunology, psychiatry and metabolic disorders; 2. Subjects with chronic or active gastrointestinal diseases such as esophageal disease, gastritis, gastric ulcer, diverticulitis, enteritis, active gastrointestinal bleeding, gastrointestinal perforation or gastrointestinal surgery within three years; 3. Subjects with heart disease (heart failure, acute myocardial infarction), pulmonary insufficiency, epilepsy (including epilepsy ourinary reter family history of epilepsy), basal ganglia lesions, Parkinson's disease, glaucoma, severe myasthenia gravis, hyperthyroidism or toxic goiter, ntion, severe central nervous depression and myelosuppression state; 4. Subjects who need drive, work high above the ground and operate machinery during the test period or one week after the trial; 5. Subjects who have a history of allergy to drugs (such as Haloperidol or any substance in this preparation), food or other substances; 6. Subjects who have had an surgical procedure during 4 weeks before the study or planned surgery during the study; 7. Treatment of any medicine (including Chinese herbal medicine and health products) within 14 days before the study; 8. Treatment of any drug that inhibited or induced the metabolism of the liver (such as the inducer-barbiturate, carbamazepine, phenytoin, glucocorticoid, omeprazole, inhibitor -SSRI antidepressants, cimetidine, diltiazem, macrolides, nitroimidazole, sedative hypnotics, and verapami, fluoroquinolones, antihistamine), any nitrate esters, alpha blocker drugs, PDE5 inhibitors and endothelin receptor antagonists 30 days before the study; 9. Subjects who vaccinated within 30 days before the study, or planned to vaccinate during the study or 3 months after the study; 10. Subjects who took any other clinical trial drug or took part in any other drug clinical trial within 3 months before the study; 11. Subjects who donated blood or had the frequency of blood loss of > 200 mL within 3 months before the study; 12. Subjects who are unable to take 1 or more contraceptive measures before the 2 weeks of study, during the trial and 3 months after the trial, and who are pregnancy, sperm donation and egg donation planners; 13. Subjects who have special requirements for diet, and can not comply with a unified diet; 14. Subjects drink excessive amounts of tea, coffee and / or beverages with caffeine or xanthine (8 cups or more, 1 cups =250 mL) per day, and do not agree to stop drinking during the study; 15. Areca addicts or those who have eaten areca within 2 days before taking the study drug, and do not agree to stop eating areca during the study; 16. Smokers or those who smoke more than 5 cigarettes per day 3 months before the study, and do not agree to stop smokeing during the study; 17. Drinkers or those who drink frequently 6 months before the study, that is, drinking more than 14 units of alcohol per week (1 unit =360 mL of beer or 45 mL of alcohol with 40% of alcohol or 150 mL of wine), and do not agree to stop drinking during the study; 18. Drug abusers or those who used soft drugs (such as cannabis) 3 months before the start of study or those who took hard drugs (such as cocaine, phencyclidine, etc.) 1 years before the start of study; 19. Subject with vasovagal syncope, poor venous and vascular conditions or diff
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Haloperidol; | — |
Contacts
Public ContactZhang Bikui
Xiangya Bo'ai Rehabilitation Hospital
Outcome results
None listed