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Background. Anagrelide is used for the treatment of essential thrombocythemia. This drug selectively aff ects thrombocytes without inducing pronounced myelosuppression, which provides a satisfactory safety profi le. Aim. To compare pharmacokinetics and to assess bioequivalence of two anagrelide drugs for oral administration in healthy volunteers. Materials & Methods. Open, randomized, two-period, two-sequence, crossover study comparing pharmacokinetics and bioequivalence of anagrelide included 30 volunteers. The participants received a single dose of either test or reference drug, depending on the study period. Serial blood samples for pharmacokinetic analysis were collected within 12 hours after drug administration. Plasma anagrelide concentration was measured by high-performance liquid chromatography/mass spectrometry. Pharmacokinetic parameters were analyzed by non-compartmental method. ANOVA analysis of variance was used for assessing the diff erence between the mean values of the AUC0-t, AUC0-∞ and Cmax pharmacokinetic parameters at 5 % signifi cance level. Results. The mean values of maximum concentration (Сmax) after a single dose of anagrelide were 12.68 ± 2.99 ng/mL and 12.46 ± 3.15 ng/mL for test and reference drugs, respectively. Relative bioavailability was 1.16  ±  0.18. The  AUC0-12 mean values calculated by anagrelide concentrations after a single dose of test and reference drugs were 30.38 ± 7.0 ng • h/mL and 28.78  ±  7.50 ng • h/mL, respectively, and the AUC0-∞ mean values were 31.13  ±  7.15 ng • h/mL and 29.55  ±  7.61 ng • h/mL, respectively. The assessment of main vital functions and laboratory parameters did not reveal any eff ect of the drugs on the health status of trial participants. 347 ht tp : / /b lood journa l . ru / Первый отечественный дженерик анагрелида Заключение. Фармакокинетический профиль тестируемого препарата (дженерика анагрелида) не имел существенных отличий по сравнению с референтным, что свидетельствует о его биоэквивалентности in vivo. Оценка безопасности препаратов показала удовлетворительную переносимость, серьезных нежелательных явлений не зарегистрировано. Ключевые слова: анагрелид, дженерик, биоэквивалентность, эссенциальная тромбоцитемия, безопасность, переносимость. Получено: 19 февраля 2020 г. Принято в печать: 25 мая 2020 г. Для переписки: Ольга Игоревна Бутранова, канд. мед. наук, ул. Миклухо-Маклая, д. 6, Москва, Российская Федерация, 117198; тел.: +7(903)376-71-40; e-mail: butranova-oi@rudn.ru, butranovaolga@mail.ru Для цитирования: Зырянов С.К., Чистяков В.В., Бутранова О.И. и др. Фармакокинетика, безопасность и переносимость первого отечественного дженерика анагрелида в сравнении с референтным препаратом. Клиническая онкогематология. 2020;13(3):346–53. DOI: 10.21320/2500-2139-2020-13-3-346-353 Conclusion. Pharmacokinetic profi le of the test drug (generic anagrelide) did not considerably diff er from that of reference drug, which indicates in vivo bioequivalence of it. The assessment of drug safety yielded satisfactory tolerance; no serious adverse events have been reported.

Pharmacokinetics, Safety, and Tolerance of Anagrelide, the First Domestic Generic, Compared with Reference Drug