Publication: Clinical Therapeutics
Abstract
This publication reports a randomized, crossover bioequivalence study of a new water-soluble progesterone injection (GenSci070) against a marketed reference formulation (Lubion) in 50 healthy Chinese postmenopausal women, following a single subcutaneous dose. Plasma progesterone was measured by LC-MS/MS and pharmacokinetic parameters derived using Phoenix WinNonlin. Geometric mean ratios for Cmax, AUC0-t, and AUC0-inf all fell within the standard bioequivalence range, and mild treatment-emergent adverse events occurred at similar rates between formulations. The results demonstrate that GenSci070 is bioequivalent to the reference progesterone injection with a comparable safety profile.
Author(s): Song R, Wu X, Xin L, Sun C, Gui Y, Qian H, Yu C, Chen Q, Luo T, Ding Y, Gao W, Zhu X, Jia J
Published: January 30, 2025
Phoenix WinNonlin: Bioequivalence for Injectables
Phoenix WinNonlin’s pharmacokinetic analysis confirmed bioequivalence between a new water-soluble progesterone injection and its reference product in this study. Phoenix WinNonlin’s results can flow directly into PK Submit for CDISC-compliant submission packages, within a Phoenix platform used by 100% of the top 20 pharma companies.
