Pharmacokinetics and Bioequivalence Study in human
Conditions
Interventions
Group A:Phase I: APT Pha. Ltd., Hong Kong produced Ezetimibe Tablets, 10 mg
Phase II: MSD International GmbH (Pureto Rico Branch) LLC, Puerto Rico Ezetimibe Tablets, 10 mg
Group B:Phase I: MSD International GmbH (Pureto Rico Branch) LLC, Puerto Rico Ezetimibe Tablets, 10 mg
Phase II: APT Pha. Ltd., Hong Kong produced Ezetimibe Tablets, 10 mg
Sponsors
Xiangya Boai Rehabilitation Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1) Aged 18 to 55 years old (including boundary values); 2) Males and females ; 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) Voluntary signing of written informed consent.
Exclusion criteria
Exclusion criteria: 1) Subjects who are allergies or allergic to any of the chemical composition in the ezetimibe tablets; 2) History of 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, or any other disease; 3) Have a history of dysphagia, digestive tract ulcers, gastrointestinal bleeding, gallstones, cholecystitis or any gastrointestinal diseases and affect the absorption of drugs, and now feel the discomfort of the digestive tract; 4) Subjects who have had an surgical procedure during 4 weeks before the study or planned surgery during the study; 5) Treatment of any medicine (including Chinese herbal medicine and health products) within 14 days before the start of the study; 6) 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 start of the study; 7) Subjects who took any other clinical trial drug or took part in any other drug clinical trial within 3 months before the study; 8) Subjects who donated blood or had the frequency of blood loss of > 200 mL within 3 months before the study; 9) Vasovagal syncope, poor vascular conditions or difficulty in puncture; 10) Subjects who are unable to take one or more contraceptive measures during the study period and within 3 months after the study; 11) Women during pregnancy and lactation; 12) Subjects who have special requirements for diet, and can not comply with a unified diet; 13) Subjects drink excessive amounts of tea, coffee and / or beverages with caffeine or xanthine (8 cups or more, 1 cups =250 mL) per day; 14) Subjects who took grapefruit or grape juice, cabbage vegetables, dragon fruits, mangoes, oranges or the related food or drink made by them within 2 days before the study; 15) Smokers or more than 5 cigarettes per day for the first 3 months of the trial; 16) Drinkers or those who drink frequently 6 months before the study, that is, drinking more than 14 units of alcohol per week (1 units =360 mL of beer or 45 mL of alcohol with 40% of alcohol or 150 mL of wine); 17) 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; 18) Subject with abnormal in vital signs (systolic pressure 140 mmHg, diastolic pressure 90 mmHg; heart rate 100 bpm; temperature 37 degree C) are of clinical significance (according to the physician's judgment); 19) Physical examination, electrocardiogram, laboratory examination abnormalities are of clinical significance (according to the physician's judgment); 20) Subject with abnormal blood pregnancy (Beta-HCG) are of clinical significance (according to the physician's judgment); 21) Other reasons that prevent the volunteers from finishing the study, or the researchers do not agree to recruit him or her; 22) Positive result of urine screening test (morphine, methamphetamine, ketamine, ecstasy, cannabis); 23) Positive results of t
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ezetimibe (unconjugated);total ezetimibe (ezetimibe + ezetimibe glucuronide); | — |
Countries
China
Contacts
Public ContactZhang Bikui
Xiangya Bo'ai Rehabilitation Hospital
Outcome results
None listed