Ignite Creation Date:
2025-12-24 @ 11:44 PM
Ignite Modification Date:
2025-12-25 @ 9:36 PM
Study NCT ID:
NCT06798051
Status:
COMPLETED
Last Update Posted:
2025-01-29
First Post:
2025-01-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Bioequivalence Study of Two Roxithromycin Tablets in Healthy Subjects
Sponsor:
The Affiliated Hospital Of Guizhou Medical University
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2025-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: