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

## TL;DR

This study compared a generic testosterone drug to a brand-name version in postmenopausal women, finding they work similarly in the body.

## Contribution

The study provides bioequivalence evidence for testosterone undecanoate in Chinese postmenopausal women under fed conditions.

## Key findings

- The generic drug showed bioequivalence to the brand-name drug with 90% confidence intervals within the accepted range.
- Pharmacokinetic parameters like Cmax and AUC were comparable between the two drugs.
- Safety and tolerability profiles were similar for both drugs.

## Abstract

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.

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.

The average adjusted geometric mean ratios (GMR) (90% CI) for the primary PK parameters Cmax, AUC0-t, and
AUC0−∞
were 102.20% (90.32%–115.63%), 99.85% (92.82%–107.41%), and 99.79% (92.90%–107.20%). All 90% CI for Cmax, AUC0-t, and
AUC0−∞
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.

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.