Randomized crossover comparative study of safety, tolerance and pharmacokinetics of primapur vs. gonal-f upon single-dose subcutaneous administration in healthy volunteers

The purpose of the current phase I study was to establish bioequivalence, safety, and tolerance of single 300 IU subcutaneous dose of primapur in comparison to that of reference follitropin alfa preparation (gonal-f) in healthy young female volunteers. No significant differences in pharmacokinetic parameters between primapur and gonal-f were detected for AUC0-192 93.31% (90% confidence interval [CI]: 87.25-99.79%) and Cmax 87.93% (90% CI: 82.85-93.33%). Both primapur and gonal-f were well tolerated, with no serious adverse events or those leading to discontinuation of treatment course. The results of this study indicate that a single dose of primapur solution for subcutaneous injection exhibits pharmacokinetic and safety profiles comparable to those of original gonal-f in healthy young women.

Авторы
Tyul'kina E.E.1 , Gordeev I.G.1, 2 , Grebenkin D.Yu. 3, 4 , Kazei V.A.3 , Tsikarishvili M.M.1 , Luchinkina E.E.2 , Abdulla B.H.2 , Samandari S.2 , Vorob'ev I.I.5 , Shigabutdinov A.F.6 , Polzikov M.A.7
Редакторы
-
Издательство
-
Номер выпуска
4
Язык
Русский
Страницы
13-17
Статус
Опубликовано
Подразделение
-
DOI
-
Номер
-
Том
80
Год
2017
Организации
  • 1 O. M. Filatov Municipal Clinical Hospital No. 15, Department of Public Health of the City of Moscow, ul. Veshnyakovskaya 23, Moscow, 111539, Russian Federation
  • 2 Pirogov Russian State Medical University, ul. Bolshaya Pirigovskaya 9a, Moscow, 119021, Russian Federation
  • 3 ExacteLabs Company, Nauchnyi proezd 20, Moscow, 117246, Russian Federation
  • 4 Institute of Biochemical Technology and Nanotechnology, Peoples' Friendship University of Russia, ul. Miklulho-Maklaya 10/2, Moscow, 117198, Russian Federation
  • 5 Fundamentals of Biotechnology, Federal Research Centre, Russian Academy of Sciences, Leninskii prosp. 33/2, Moscow, 119071, Russian Federation
  • 6 Nadim Company, ul. 4-ya Magistralnaya 11/2, Moscow, 123007, Russian Federation
  • 7 IVFarma Company, Nauchnyi proezd 20/2, Moscow, 117246, Russian Federation
Ключевые слова
Bioequivalence; Clinical trials; Follitropin alfa; In vitro fertilization; Phase I; Primapur; Recombinant human follicle-stimulating hormone
Дата создания
19.10.2018
Дата изменения
19.10.2018
Постоянная ссылка
https://repository.rudn.ru/ru/records/article/record/6310/