Pharmacokinetics and Bioequivalence Study in human
Conditions
Interventions
Group A:Period I: Reference Preparation (Arcoxia Tab 120mg, Frosst Iberica, S.A.)
Period II: Trial Preparation (Syncoxia Tablets 120 mg, SYNCO (H.K.) LIMITED)
Group B:Period I: Trial Preparation (Syncoxia Tablets 120 mg, SYNCO (H.K.) LIMITED)
Period II: Reference Preparation (Arcoxia Tab 120mg, Frosst Iberica, S.A.)
Sponsors
Xiangya Bo'ai Rehabilitation Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Chinese healthy male or female, aged >= 18 years; 2.Male weight >= 50 kg, female weight >= 45 kg, body mass index (BMI) between 19-26 kg/m^2 (BMI = weight (kg)/height ^2 (m^2)), including boundary value; 3.The subjects who voluntarily sign the written informed consent before the trial, and have a thorough understanding of the trail content, process and possible adverse reactions; 4.The subjects who are able to communicate well with the investigator and comply with the requirements of the trial.
Exclusion criteria
Exclusion criteria: Screening period: 1.Subjects who took part in any other clinical trial within 3 months before the study; 2.Subjects suffering from gastrointestinal diseases (such as habitual constipation, diarrhea, esophageal disease, gastritis, gastric ulcer, active gastrointestinal bleeding, gastrointestinal perforation, crohn's disease) or gastrointestinal surgery within 3 years before the study, and still having clinical significance according to the investigator's judgment; 3.History suffering from any clinical disease (such as motor system, digestive system, respiratory system, urinary system, reproductive system, endocrine system, immune system, nervous system and circulatory system) and still having clinical significance according to the investigator's judgment; 4.History suffering from edema and hypertension; myocardial infarction, stroke, congestive heart failure, ischemic heart disease, peripheral artery disease and/or cerebrovascular disease (including coronary artery bypass grafting or angioplasty, recently) and still having clinical significance according to the investigator's judgment; 5.Subjects who have a history of anaphylaxis after taking this drugs, have a history of asthma, urticaria, or anaphylaxis after taking aspirin/other NSAIDs or suffers from allergies; 6.Subject who cannot tolerate venipuncture or history suffering from blood phobia or acupuncture syncope; 7.Subjects who have had an surgical procedure ,during 6 month before the study, which could affect drug absorption, distribution, metabolism and excretion according to the investigator's judgment, or had an surgical procedure during 4 weeks before the study, or planned surgery during the study; 8.Subjects who treated with any medicine (including Chinese herbal medicine and vitamin), health products within 14 days before the study; 9.Subjects who treated with any drug that inhibited or induced the metabolism of the liver; 10.Subjects who vaccinated within 14 days before the study, or planned to vaccinate during the study (including attenuated live vaccine and COVID-19 vaccine); 11.Subjects who donated blood or had the blood loss of > 200 mL within 3 months before the study, or planned to donat blood 3 months after the study; 12.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; 13.Smokers or those who smoke more than 5 cigarettes per day 3 months before the study, or do not agree to stop smokeing during the study; 14.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), or do not agree to stop drinking during the study; 15.Subjects drink excessive amounts of tea, coffee and / or beverages with caffeine or xanthine (8 cups or more, 1 cups =250 mL) per day, or do not agree to stop drinking during the study; 16.Subjects who have special requirements for diet, and can not comply with a unified diet; 17.Subjects who suffering from lactose intolerance; 18.Subjects who had unprotected sex before the 2 weeks of study , subjects or their spouse (or partner) had a pregnancy or sperm donation plan during and 6 months after the study, and are unable to take 1 or more non-drug contraceptive measures (such as total abstinence, intrauterine ring, ligation) during the study;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax;AUC0-t;AUC0-8; | — |
Countries
China
Contacts
Public ContactZhang Bikui
The Second Hospital of Centrral South University
Outcome results
None listed