A Single-Dose, Three-Way, Three-Sequence, Crossover BA Study of Azithromycin Oleogel
Status:
Not yet recruiting
Trial end date:
2023-12-01
Target enrollment:
Participant gender:
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.