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

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.