Bioequivalence study in healthy Thai volunteers Ticagrelor 90 mg Tablet Bioequivalence study, Healthy
Conditions
Interventions
Each film coated tablet contains, Ticagrelor 90 m,Each tablet contains, Ticagrelor 90 mg, Brilinta 90 mg, Reg. No. 1 C 32/59 (N)
Experimental Drug,Active Comparator Drug
Generic name: Ticagrelor 90 mg Film-coated Tablet,: Ticagrelor film-coated tablet 90 mg, Brilinta 90 mg
Sponsors
International Bio Service Co., Ltd.
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1. Non-smoker, healthy Thai male or female subjects between the ages of 18 to 55 years (both inclusive). 2. Body mass index between 18.5 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 6 months 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. hyper/hypothyroidism, diabetes mellitus), pulmonary or respiratory (e.g. asthma), cardiovascular (e.g. hyper-/hypotension), psychiatric, neurologic (e.g. convulsion), allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) or any significant ongoing chronic medical illness. 3. History or evidence of clinically significant active bleeding or gastrointestinal bleeding or peptic ulcer. 4. History or evidence of intracranial hemorrhage, ischemic stroke, myocardial infarction or coronary artery bypass grafting (CABG). 5. History or evidence of recent surgery or recent trauma within 14 days prior to check-in in each period. 6. Have abnormality of prothrombin time (PT) and activated partial thromboplastin time (aPTT). 7. History or evidence of coagulation disorders, hepatic disease associated with coagulopathy or clinically relevant bleeding risk. 8. History or evidence of thrombotic thrombocytopenic purpura. 9. History or evidence of gout or hyperuricemia. 10.Investigation with blood sample shows hyperuricemia, a serum urate level greater than 5.7 mg/dL in women and 7.0 mg/dL in men at screening laboratory test. 11.History or evidence of severe hepatic impairment. 12.History or evidence of dyspnea. 13.History of problems with swallowing tablet or capsule. 14.History of sensitivity to heparin or heparin-induced thrombocytopenia. 15.Any condition possibly affecting drug absorption e.g. gastrectomy, enterectomy, gastritis or duodenal or gastric ulceration other than appendectomy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax, AUC0-tlast and AUC0-inf will be determined from the plasma concentration data of analytes. 0-48 hours post dose Mass spectrometry (LC-MS/MS) | — |
Secondary
| Measure | Time frame |
|---|---|
| Tmax, t1/2, AUC0-tlast/AUC0-inf, AUC%extrapolate, lambdaz and MRT will be determined from the plasma concentration data of analytes 0-48 hours post dose Mass spectrometry (LC-MS/MS) | — |
Countries
Thailand
Contacts
Public ContactPorranee Puranajoti
International Bio Service Co., Ltd.
Outcome results
None listed