A Single Dose, Randomized, Open-label, Two-way Crossover Bioequivalence Study of Test Product (Ticagrelor FCT 90 mg; Manufactured by MSN Laboratories Private Limited, India) and Reference Product (BRILINTATM; Manufactured by AstraZeneca AB, Sweden) in Healthy Thai Volunteers under Fasting Conditions

Phase 1

• Conditions: Bioequivalence Study Healthy Volunteers; Ticagrelor Film-coated tablets 90 mg Bioequivalence Study Healthy Volunteers

• Registration Number: TCTR20210302004
• Lead Sponsor: International Bio Service Co., Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-03-02
• Study Completion: 2021-06-11
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending (Not yet recruiting)
• Sex: All
• Target Recruitment: 32

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Ticagrelor and AR-C124910XX plasma concentration 19 points 0-48 hrs post dose Cmax, AUC0-tlast, AUC infinity

Secondary Outcome Measures

Name	Time	Method
Ticagrelor and AR-C124910XX plasma concentration 19 points 0-48 hrs post dose Tmax, t1/2, elimination rate constant