Bioequivalence Study Healthy Volunteers Ticagrelor Film-coated tablets 90 mg Bioequivalence Study Healthy Volunteers
Conditions
Interventions
Generic Ticagrelor Film-coated tablets 90 mg. Each Tablet contains 90 mg Ticagrelor,Ticagrelor 90 mg Film-coated Tablets, BRILINTATM,
Reg. No. 1C 32/59, manufactured by AstraZeneca AB.
Each tablet co
Experimental Drug,Active Comparator Drug
Test (T) Ticagrelor Film-coated tablets 90 mg,Reference (R) 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/m2. 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. 6.Male subjects who are willing or able to use effective contraceptive e.g. condom or abstinence after admission in Period 1 until 7 days after the end of study in Period 2.
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. hyper-/hypothyroid, diabetes), pulmonary or respiratory (e.g. asthma), cardiovascular, 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 or evidence of clinically significant active bleeding 5.History or evidence of intracranial hemorrhage, ischemic stroke or myocardial infarction 6.History or evidence of recent surgery or recent trauma within 14 days prior to check-in in each period 7.History or evidence of gastrointestinal bleeding or peptic ulcer 8.History or evidence of coronary artery bypass grafting (CABG) 9.History or evidence of coagulation disorders, hepatic disease associated with coagulopathy or clinically relevant bleeding risk 10.History or evidence of gout or hyperuricaemia 11.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. 12.History or evidence of thrombotic thrombocytopenic purpura 13.History or evidence of severe hepatic impairment 14.History or evidence of dyspnea
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ticagrelor and AR-C124910XX plasma concentration 19 points 0-48 hrs post dose Cmax, AUC0-tlast, AUC infinity | — |
Secondary
| Measure | Time frame |
|---|---|
| Ticagrelor and AR-C124910XX plasma concentration 19 points 0-48 hrs post dose Tmax, t1/2, elimination rate constant | — |
Countries
Thailand
Contacts
Public ContactUthai Suvanakoot
International Bio Service Co., Ltd
Outcome results
None listed