What does this research mean for the field?

Testosterone undecanoate (TU) is bioequivalent to the originator drug Andriol Testocaps ® in healthy postmenopausal women under fed conditions. Novelty: ClaimNovelty.CONFIRMATORY. Consensus alignment: ConsensusAlignment.SUPPORTS_CONSENSUS.

What question did this study set out to answer?

The study aims to assess the pharmacokinetics and bioequivalence of testosterone undecanoate compared to Andriol Testocaps in healthy postmenopausal women.

March 6, 2026SHILAP Revista de lepidopterología0 citationsOpen Access

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

NLNanxing LiZhejiang Medicine (China)FZFengjia ZhuShenyang Pharmaceutical University ZZZhongyuan ZhaoBinghamton University

Puntos clave

The study aims to assess the pharmacokinetics and bioequivalence of testosterone undecanoate compared to Andriol Testocaps in healthy postmenopausal women.
Randomized, open-label, two-treatment, four-period design
Single-dose crossover trial
Participants received 40 mg testosterone undecanoate or Andriol Testocaps
Serial blood samples collected for 24 hours post-dose
Average GMR for C max was 102.20% (90% CI: 90.32%–115.63%)
Average GMR for AUC 0-t was 99.85% (90% CI: 92.82%–107.41%)
Average GMR for AUC 0-∞ was 99.79% (90% CI: 92.90%–107.20%)
All PK parameters fell within the bioequivalence range of 80%–125%

Resumen

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.

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