NCT06798051

Bioequivalence Study of Two Roxithromycin Tablets in Healthy Subjects

A Single-dose, Fasting, Randomized, Open-label, Two-treatment, Three-period, Partially-replicated, Reference-corrected Crossover Bioequivalence Study of Roxithromycin Tablets in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 39 (actual)
• Sponsor: The Affiliated Hospital Of Guizhou Medical University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Roxithromycin is used for the treatment of pharyngitis and tonsillitis caused by Streptococcus pyogenes, sinusitis, otitis media, acute bronchitis, acute exacerbations of chronic bronchitis, and pneumonia caused by Mycoplasma pneumoniae or Chlamydia pneumoniae; urethritis and cervicitis caused by Chlamydia trachomatis; and skin and soft tissue infections caused by susceptible bacteria. The purpose of this study was to evaluate the bioequivalence of roxithromycin tablets from two different manufacturers after fasting administration in healthy subjects and to observe the safety of the test and reference preparations in healthy subjects.

Conditions

• Bioequivalence of Roxithromycin Tablets From Two Different Manufacturers

Interventions

Type	Name	Description
DRUG	Roxithromycin tablets 150mg	Oral roxithromycin tablets，150mg Once every seven days，One cycle T drug, two cycles R drug

Timeline

• Start date: 2019-06-03
• Primary completion: 2019-08-06
• Completion: 2019-09-03
• First posted: 2025-01-29
• Last updated: 2025-01-29

Locations

1 site across 1 country: China