NCT02237807

Semi-replicate Crossover Bioequivalence Study of Dirithromycin in Healthy Subjects Under Fed Conditions

Comparative, Randomized, Three -Period, Two-treatment, Three -Sequence, Open Label, Semi-replicate Crossover Bioequivalence Study of Dirithromycin 500 mg Enteric Coated Tablet (One Tablet) of (Abdi İbrahim İlaç San. Ve Tic. A. Ş., Turkey) Versus Dynabac 250 mg Enteric Coated Tablet (Two Tablets) of (Abdi İbrahim İlaç San. Ve Tic. A. Ş., Turkey) in Healthy Subjects Under Fed Conditions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Pharmaceutical Research Unit, Jordan · Academic / Other
• Sex: Male
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

Detailed description

An open-label, randomized, two-treatments, three-periods, three-sequences, semi-replicate crossover bioequivalence study with a washout period of at least 14 days between doses. Healthy, mixed skin Arab \& Mediterranean Subjects ages between 18 and 50 years, body-mass index 18.5 to 30.0 kg/m2 inclusive (minimum of 50 kg weight), non-smokers or light smokers (smokers of not more than 10 cigarettes per day).

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	DIRITHROMYCIN 500 MG ENTERIC COATED TABLET
DRUG	DYNABAC 250 MG ENTERIC COATED TABLET

Timeline

• Start date: 2014-09-01
• Primary completion: 2014-10-01
• Completion: 2014-10-01
• First posted: 2014-09-11
• Last updated: 2020-09-18

Locations

1 site across 1 country: Jordan