Bioequivalence Study in Healthy Thai Volunteers Ticagrelor 90 mg Film-coated Tablets in Healthy Thai Volunteers under Fasting Conditions
Conditions
Interventions
Each tablet contains 90 mg of ticagrelor , manufactured by Exemed Pharmaceuticals,Each tablet contains 90 mg of ticagrelor, BRILINTA, Reg. No. of Philippines DR-XY40759, manufactured by AstraZeneca AB
Experimental Drug,Active Comparator Drug
Test (T): Generic ticagrelor 90 mg film-coated tablet,Reference (R): Ticagrelor 90 mg film-coated tablet, BRILINTA
Sponsors
International Bio Service Co., Ltd.
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1.Healthy Thai male or female subjects between the ages of 18 to 55 years, 2.Body mass index between 18.0 to 30.0 kg per square meter, 3. Normal laboratory values, including vital signs and physical examination, for all parameters in clinical laboratory tests at screening. Any abnormalities from the normal or reference range will be carefully considered clinically relevant by the physician as individual cases, documented in study files prior to enrolling the subject in this study, 4.Non pregnant woman (negative pregnancy test) and not currently breast feeding, 5. Female subjects abstain from either hormonal methods of contraception (including oral or transdermal contraceptives, injectable progesterone, progestin subdermal implants, progesterone-releasing IUDs, postcoital contraceptive methods) or hormone replacement therapy for at least 28 days prior to check-in in Period 1. Injectable contraceptives e.g. Depo-Provera will be discontinued at least 6 months prior to check-in in Period 1. Subjects agree to use acceptable non-hormonal contraceptive methods such as condom, diaphragm, foams, jellies, or abstinence for at least 14 days prior to check-in in Period 1 until 7 days after the end of study in Period 2. Female subjects of non-childbearing potential must meet at least one of the following criteria prior to check-in in Period 1: Postmenopausal for at least 1 year or Surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy) at least 6 months, 6.Male subjects who are willing or able to use effective contraceptive e.g. condom or abstinence after check-in in Period 1 until 7 days after the end of study in Period 2, 7.Have voluntarily given written informed consent (signed and dated) by the subject prior to participating in this study.
Exclusion criteria
Exclusion criteria: 1. History of allergic reaction or hypersensitivity to ticagrelor or to any component of the product, 2. History or evidence of clinically significant renal, hepatic, gastrointestinal, hematological (e.g. anemia), endocrine (e.g. hypo-/hyperthyroid, diabetes), pulmonary or respiratory (e.g. asthma), cardiovascular (e.g. hypo-/hypertension), psychiatric (e.g. depression), neurologic (e.g. convulsant), allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) or any significant ongoing chronic medical illness, 3. Have high risk for coronavirus infection based on risk assessment questionnaire or diagnosed as confirmed case of COVID-19, 4. History about administration of COVID-19 vaccine within 30 days prior to check-in in each Period, 5. History or evidence of clinically significant active bleeding, 6. History or evidence of intracranial hemorrhage, ischemic stroke or myocardial infarction, 7. History or evidence of recent surgery or recent trauma within 14 days prior to check-in in each period, 8. History or evidence of gastrointestinal bleeding or peptic ulcer, 9. History or evidence of coronary artery bypass grafting (CABG), 10. History or evidence of coagulation disorders, hepatic disease associated with coagulopathy or clinically relevant bleeding risk, 11. History or evidence of gout or hyperuricaemia, 12. Investigation with blood sample shows hyperuricaemia, a serum urate level greater than 6.0 mg/dL in women and 7.0 mg/dL in men at screening laboratory test, 13. History or evidence of thrombotic thrombocytopenic purpura, 14. History or evidence of severe hepatic impairment, 15. History or evidence of dyspnea, 16. History or evidence of bradycardia, 17. History of problems with swallowing tablet or capsule, 18. History or evidence of galactose intolerance, the Lapp lactase deficiency or glucosegalactose malabsorption, 19. History of sensitivity to heparin or heparin-induced thrombocytopenia, 20. Any condition possibly affecting drug absorption e.g. gastrectomy, enterectomy, gastritis or duodenal or gastric ulceration other than appendectomy, 21. History of vomiting or diarrhea within 24 hours prior to check-in in each period, 22. History or evidence of drug addict or investigation with urine sample shows a positive test for drug of abuse (morphine, marijuana or methamphetamine), 23. 12-lead ECG demonstrating QTc >450 msec, a QRS interval >120 msec or with an abnormality considered clinically significant at screening. If QTc exceeds 450 msec, or QRS exceeds 120 msec, the ECG will be repeated two more times and the average of the three QTc or QRS values will be used to determine the subject' s eligibility, 24. Investigation with blood sample shows positive test for HBsAg, 25. Abnormal liver function, ?1.5 times of upper normal limit of reference range for ALT, AST or bilirubin levels at screening laboratory test, 26. History or evidence of habitual use of tobacco or nicotine containing products and cannot abstain for at least 48 hours prior to check-in in Period 1 and continued for entire duration of the study, 27. History or evidence of alcoholism or harmful use of alcohol (less than 2 years) i.e., alcohol consumption of more than 14 standard drinks per week for men and 7 standard drinks per week for women (A standard drink is defined as 360 mL of beer or 150 mL of wine or 45 mL of 40% distilled spirits, such as rum, whisky, brandy etc.), 28. History or evidenc
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ticagrelor 0-48 hours Cmax, AUC0-tlast and AUC0-infinity | — |
Secondary
| Measure | Time frame |
|---|---|
| Ticagrelor 0-48 hours Tmax, t1/2, AUC0-tlast/AUC0-infinity | — |
Countries
Thailand
Contacts
Public ContactUthai Suvanakoot
International Bio Service Co., Ltd.
Outcome results
None listed