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A Bioequivalence Study of Glibenclamide From Glibesyn 5 mg Tablets (Medochemie LTD Cyprus) and Daonil 5 mg Tablets (Sanofi-Aventis Cyprus Ltd. )

NCT03855306 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2019-02-26

No results posted yet for this study

Summary

Comparative randomized, single dose, two-way crossover open-label study to determine the bioequivalence of Glibenclamide from Glibesyn 5 mg tablets (Manufactured by Medochemie LTD Cyprus) and Daonil 5 mg tablets (Sanofi-Aventis Cyprus Ltd. ) after a single oral dose administration of each to healthy adults under fasting conditions

Conditions

  • Healthy

Interventions

DRUG

Glibesyn

1 tablet contains 5 mg Glibenclamide

DRUG

Daonil

1 tablet contains 5 mg Glibenclamide

Sponsors & Collaborators

  • Medochemie LTD Cyprus

    collaborator UNKNOWN

  • Genuine Research Center, Egypt

    lead INDUSTRY

Principal Investigators

  • Ahmed Elshafeey, Ph.D. Pharma · Genuine Research Center

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-06-30
Primary Completion
2018-07-07
Completion
2018-08-15

Countries

  • Egypt

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 NCT03855306 on ClinicalTrials.gov