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

NCT02237807 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2020-09-18

No results posted yet for this study

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.

Conditions

  • Healthy

Interventions

DRUG

DIRITHROMYCIN 500 MG ENTERIC COATED TABLET

DRUG

DYNABAC 250 MG ENTERIC COATED TABLET

Sponsors & Collaborators

  • Abdi Ibrahim Ilac San. ve Tic A.S.

    collaborator INDUSTRY

  • Pharmaceutical Research Unit, Jordan

    lead OTHER

Principal Investigators

  • Rana T Bustami, Phd.pharmacy · PRU

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-09-30
Primary Completion
2014-10-31
Completion
2014-10-31

Countries

  • Jordan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02237807 on ClinicalTrials.gov