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Bioequivalence Study of Two Roxithromycin Tablets in Healthy Subjects

NCT06798051 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2025-01-29

No results posted yet for this study

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

DRUG

Roxithromycin tablets 150mg

Oral roxithromycin tablets，150mg Once every seven days，One cycle T drug, two cycles R drug

Sponsors & Collaborators

  • The Affiliated Hospital Of Guizhou Medical University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-06-03
Primary Completion
2019-08-06
Completion
2019-09-03

Countries

  • China

Study Locations

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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 NCT06798051 on ClinicalTrials.gov