A Single-Dose, Three-Way, Three-Sequence, Crossover BA Study of Azithromycin Oleogel

Summary

This is an exploratory study to describe the pharmacokinetics of the azithromycin oral and rectal oleogel in humans compared to the reference oral drug to (Zithromax) assess the impact of the novel formulation on bioavailability. The investigators will perform a randomized, balanced, single dose, three-treatment, three-period, crossover oral bioavailability study under fasted conditions to evaluate the safety and tolerability of azithromycin oleogel and compare the bioavailability of the azithromycin oleogel to the reference drug.

Timeline

Start

2024-08-08

Primary completion

2025-11-25

Completion

2025-11-25

Drugs

Indications