Clin Pharmacol Drug Dev. 2026 Feb;15(2):e70025. doi: 10.1002/cpdd.70025.

ABSTRACT

The growing demand for assisted reproductive technology (ART) has increased the need for effective luteal phase support. Progesterone, essential for maintaining early pregnancy, is a critical component of ART. This open-label, balanced, randomized, two-treatment, crossover, single-dose study compared the bioequivalence of aqueous progesterone 25 mg injection (AqSusten^® [Test, Sun Pharma Laboratories Limited]), compared to the innovator’s aqueous progesterone 25 mg injection (Lubion^® [Reference, IBSA Farmaceutici Italia Srl]), in healthy postmenopausal women under fasting conditions. Forty-eight subjects received either treatment in Period 1, followed by alternate treatment in Period 2, with a 14-day washout period. Pharmacokinetics (C_max, AUC_0-t, AUC_0-∞) and mean plasma concentration-time profiles were assessed. Forty-five subjects completed the study. Pharmacokinetic data for both products were comparable, with percentage ratios for AUC_0-t, AUC_0-∞, and C_max of 99.16%, 98.78%, and 103.36%, respectively, within the acceptable bioequivalence range of 80%-125%. Plasma concentration-time profiles were similar, and no serious adverse events were reported. Mild adverse events with Lubion^® included increased white blood cell count and blood glucose. AqSusten^® demonstrated bioequivalence to Lubion^® in healthy postmenopausal women under fasting conditions. Both formulations exhibited similar pharmacokinetic profiles, with favorable safety and tolerability, suggesting AqSusten^® as a viable alternative in ART treatments.

PMID:41641846 | DOI:10.1002/cpdd.70025