Overview

Semi-replicate Crossover Bioequivalence Study of Dirithromycin of (Abdi İbrahim İlaç San. Ve Tic. A. Ş., Turkey) in Healthy Subjects Under Fasting Conditions

Status:
Completed

Trial end date:
2014-12-01

Target enrollment:

Participant gender:

Summary

The purpose of this study is to assess the bioequivalence of the investigational TEST product with the marketed REFERENCE products by measurement of Plasma concentrations of Erythromycylamine and calculation of the bioequivalence parameters from those measurements followed by ANOVA and 90% confidence interval statistical evaluation.

Phase:

Phase 1

Details

Lead Sponsor:

Pharmaceutical Research Unit, Jordan

Collaborator:

Abdi Ibrahim Ilac San. ve Tic A.S.

Treatments:

Dirithromycin
Erythromycin