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
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,...
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Published in | International journal of clinical pharmacology and therapeutics Vol. 59; no. 12; pp. 794 - 803 |
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Main Authors | , , , , , , |
Format | Journal Article |
Language | English |
Published |
Munich
Dustri - Verlag Dr. Karl Feistle GmbH & Co. KG
01.12.2021
Dustri-Verlag Dr. Karl Feistle |
Subjects | |
Online Access | Get full text |
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Summary: | 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 AUCt and Cmax 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 AUCt and 1.17 (1.0946 – 1.2490) for Cmax, 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 AUCt and Cmax were both within 0.8000 – 1.2500, thus the two formulations are bioequivalent. |
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ISSN: | 0946-1965 |
DOI: | 10.5414/CP204040 |