First pre-filled pen device with highly purified human menopausal gonadotropin (HP-hMG, Menopur) in liquid is shown to be bioequivalent to powder for reconstitution.

Autor: Jonker DM, Koch M, Larsson P, Ravi A, Buur Rasmussen B, Speer R, Mannaerts B
Jazyk: angličtina
Zdroj: International journal of clinical pharmacology and therapeutics [Int J Clin Pharmacol Ther] 2021 Dec; Vol. 59 (12), pp. 794-803.
DOI: 10.5414/CP204040
Abstrakt: Objective: To determine whether serum human follicle-stimulating hormone (FSH) levels after single subcutaneous dosing of highly purified human menopausal gonadotropins (HP-hMG) in a liquid formulation and a powder formulation are bioequivalent.
Materials and Methods: This was a randomized, two-way, crossover, single-dose, bioequivalence trial comparing Menopur liquid injected by pre-filled pen, with Menopur powder injected by conventional syringe and needle. The primary endpoints were AUC t and C max of baseline-adjusted FSH. Pituitary-suppressed, healthy women were administered single subcutaneous injections of 450 IU Menopur liquid (600 IU/0.96 mL) and 450 IU Menopur powder (by 2 subcutaneous injections of 225 IU in 1 mL) in a randomized order. The pharmacokinetic parameters of FSH and human chorionic gonadotropin (hCG) were assessed by non-compartmental methods with adjustment for endogenous pre-dose levels.
Results: In total, 76 women were randomized, and 56 completed the trial. The mean FSH and hCG serum concentration-time profiles were comparable between the two HP-hMG formulations. The geometric mean ratios and 90% confidence intervals of FSH for HP-hMG liquid versus HP-hMG powder were 1.12 (1.0562 - 1.1889) for AUC t and 1.17 (1.0946 - 1.2490) for C max , showing that the two formulations were bioequivalent. The incidence and severity of adverse events were similar between the two preparations, and both preparations were well tolerated.
Conclusion: The 90% CIs for the geometric mean ratios of serum FSH AUC t and C max were both within 0.8000 - 1.2500, thus the two formulations are bioequivalent.
Databáze: MEDLINE
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