Semi-replicate Crossover Bioequivalence Study of Dirithromycin in Healthy Subjects Under Fed Conditions
Status:
Completed
Trial end date:
2014-10-01
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 in plasma and calculation of the bioequivalence parameters from those
measurements followed by ANOVA and 90% confidence interval statistical evaluation.