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Bioequivalence Study of Azithromycin Capsule and Reference Formulation Sumamed * in Healthy Adult Subjects in China

Upper Respiratory Tract Infection Clinical Trial

Official title:
A Single-center, Open-label, Randomized, Single-dose, Crossover Study to Compare the Equivalence of the Fasting Oral Test Formulation Azithromycin Capsule to Reference Formulation Sumamed *in Healthy Adult Chinese Subjects

Clinical Trial Summary

Main research purpose To investigate the pharmacokinetics of the test preparation azithromycin capsule and the reference preparation azithromycin capsule (Sumamed®) in Chinese healthy adult subjects by single oral administration in fasting state, and to evaluate the bioequivalence of the two preparations by oral administration in fasting state. Secondary research purpose To investigate the safety of the test preparation azithromycin capsule and the reference preparation "Sumamed®" in healthy subjects.

Clinical Trial Description

The fasting trial was designed with single-center, open, randomized, single-dose, two-cycle, two-sequence and cross-dosing trials. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06149117
Study type Interventional
Source Peking University People's Hospital
Contact
Status Completed
Phase Phase 4
Start date November 16, 2022
Completion date April 3, 2023
View Details
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