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: | Runa Speer, Bernadette Mannaerts, Birgitte Buur Rasmussen, Per Larsson, Manuela Koch, Daniël M Jonker, Arjun Ravi |
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| Jazyk: | angličtina |
| Rok vydání: | 2021 |
| Předmět: |
endocrine system
Menotropins medicine.drug_class Cmax highly purified hMG Bioequivalence Pharmacology Human chorionic gonadotropin serum FSH Pharmacokinetics Ovulation Induction medicine Humans Pharmacology (medical) Syringe bioequivalence business.industry Therapeutic Equivalency Female Gonadotropin Geometric mean Follicle Stimulating Hormone Powders business serum hCG Research Article |
| Zdroj: | International Journal of Clinical Pharmacology and Therapeutics |
| ISSN: | 0946-1965 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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