Bioequivalence study of testosterone undecanoate soft capsules in healthy postmenopausal women under fed conditions: a single-center, four-period, repeated crossover trial

Purpose This study aimed to systematically evaluate the pharmacokinetics, bioequivalence, and safety of a single postprandial oral dose of testosterone undecanoate (TU) and its originator drug Andriol Testocaps ® in healthy postmenopausal Chinese women, providing theoretical support for optimizing hormone replacement therapy protocols. Methods A randomized, open-label, two-treatment, four-period, single-center, single-dose crossover clinical trial was conducted at Xinxiang Central Hospital. Participants received single oral doses of 40 mg TU or Andriol Testocaps ® in each period. Serial blood samples were collected from 0 to 24 h post-dose. Results The average adjusted geometric mean ratios (GMR) (90% CI) for the primary PK parameters C max , AUC 0-t , and AUC 0 − ∞ were 102.20% (90.32%–115.63%), 99.85% (92.82%–107.41%), and 99.79% (92.90%–107.20%). All 90% CI for C max , AUC 0-t , and AUC 0 − ∞ fell within the 80%–125% bioequivalence range. The two drugs showed comparable results for the other PK parameters. These results indicate that the two drugs were bioequivalent. Conclusion TU demonstrated bioequivalence to Andriol Testocaps ® under fed conditions in Chinese healthy participants, with comparable safety and tolerability profiles. These results advocate the clinical application of generic TU as a potential alternative to originator drug Andriol Testocaps ® in the treatment.