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

NCT05796362 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2026-02-04

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Azithromycin Oleogel (Oral and Rectal)

Exploratory study of a novel "oleogel" dosage form of Azithromycin (Zithromax)

Sponsors & Collaborators

  • Bill and Melinda Gates Foundation

    collaborator OTHER

  • Brigham and Women's Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-08-08
Primary Completion
2025-11-25
Completion
2025-11-25
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05796362 on ClinicalTrials.gov