drugset / Trial / NCT06462326
A Study to Compare the Effect of Omadacycline Versus Moxifloxacin in Healthy Adult Volunteers
RandomizedParallel-groupTriple-blindHealth-services research
Summary
This is a randomized (1:1), double-blind, double-dummy, phase I study to compare the effects of Omadacycline versus Moxifloxacin on gut microbiota and the resistomes in healthy adult volunteers.The study consists of 3 phases: Screening, double-blind treatment, and follow-up. Healthy volunteers aged 18-40 years, who meet entry criteria, are randomly assigned to a treatment group using an Interactive Voice Response System/Interactive Web Response System (IxRS) and receive the first dose of the study drug.
Timeline
- Start
- 2024-04-16
- Primary completion
- 2024-09-29
- Completion
- 2024-09-29
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Moxifloxacin | Small molecule | 400 mg | Oral |
| Subject | Omadacycline | Small molecule | 300 mg | Oral |
Indications
No indication recorded.