生物学的同等性とバイオアベイラビリティのジャーナル

概要

Bioequivalence Study of Two Ticagrelor 90 mg Tablets in Healthy Thai Volunteers under Fasting Conditions

Anas Sunhem, Suchada Rakphung, Charinthon Seeduang, Sumate Kunsa-ngiem, Vipada Khaowroongrueng, Busarat Karachot, Piengthong Narakorn, Porranee Puranajoti, Isariya Techatanawat

Patients with acute coronary syndrome require antiplatelet therapy to reduce risk of thrombotic cardiovascular events. Ticagrelor is a potent oral antiplatelet agent that reversibly binds to P2Y12 Adenosine Diphosphate (ADP) receptor thereby preventing platelet aggregation. Since the use of ticagrelor is manageable in outpatient setting, the Government Pharmaceutical Organization (GPO), Thailand had developed a generic product of ticagrelor 90 mg tablets to reduce cost of treatment and improve accessibility to medicines for Thai patients. An open label, randomized, two-way crossover, single dose bioequivalence study was conducted under fasting conditions. The ANOVA showed no significant effects of sequence, formulation and period on the ln-transformed primary pharmacokinetic parameters. The 90% confidence intervals for the ratio of geometric least squares mean were 97.95%-108.87%, 98.21%-109.10% and 89.71%-107.78% for AUC_0-tlast, AUC_0-∞ and C_max, respectively. Both treatments were well tolerated by the study subjects. It could be inferred that two tablet formulations were bioequivalent and could be used interchangeably regarding the similarity on the pharmacokinetics and tolerability.