NCT06149117

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Peking University People's Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed description

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

Conditions

• Upper Respiratory Tract Infection
• Lower Respiratory Infection
• Skin Infection
• Subcutaneous Tissues Infection
• Genital Infection

Interventions

Type	Name	Description
DRUG	test product (T) azithromycin capsule and reference product (R) azithromycin capsule "Sumamed®"	Take one capsule orally every cycle(T or R)

Timeline

• Start date: 2022-11-16
• Primary completion: 2023-04-03
• Completion: 2023-04-03
• First posted: 2023-11-28
• Last updated: 2023-11-28

Locations

1 site across 1 country: China