A comparative pharmacokinetic evaluation of two aqueous progesterone 25 mg injections in healthy postmenopausal women under fasting conditions: An open-label, balanced, randomized, two-treatment, two-period, two-sequence, single-dose, crossover bioequivalence study.

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 (Cmax, AUC0-t, AUC0-∞) 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 AUC0-t, AUC0-∞, and Cmax 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.