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Bioequivalence Study of Vildagliptin From Gliptus 50 mg Tablet (EVA Pharma, Egypt) and Galvus 50 mg Tablet (NOVARTIS PHARMA, GERMANY)

NCT02816970 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2016-06-29

No results posted yet for this study

Summary

An open label randomized, single dose, two-way crossover bioequivalence study to determine the bioequivalence of Vildagliptin from Gliptus 50 mg tablet (EVA pharma, Egypt) and Galvus 50 mg tablet (NOVARTIS PHARMA, GERMANY) in Healthy Human Volunteers Under Fasting Condition

Conditions

  • Healthy

Interventions

DRUG

Vildagliptin

1 tablet contains 50 mg vildagliptin

DRUG

Vildagliptin

1 tablet contains 50 mg vildagliptin

Sponsors & Collaborators

  • Eva Pharma

    collaborator INDUSTRY

  • Genuine Research Center, Egypt

    lead INDUSTRY

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2014-02-28
Primary Completion
2014-02-28
Completion
2014-03-31

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 NCT02816970 on ClinicalTrials.gov