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Bioequivalence Study of Linagliptin From Prevaglip 5 mg Tablets(Eva Pharma, Egypt) and Trajenta 5 mg Tablets (Boehringer Ingelheim International GmbH, Germany)

NCT02857946 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2016-08-05

No results posted yet for this study

Summary

An open label randomized, single dose, two-way crossover bioequivalence study to determine the bioequivalence of Linagliptin from Prevaglip 5 mg tablets(Eva pharma for Pharmaceuticals \& Medical Appliances, Egypt) and Trajenta 5 mg tablets(Boehringer Ingelheim International GmbH, Germany) after a single oral dose administration of each to healthy adults under fasting conditions

Conditions

  • Healthy

Interventions

DRUG

Prevaglip (linagliptin)

1 tablet contains 5 mg linagliptin

DRUG

Trajenta (linagliptin)

1 tablet contains 5 mg linagliptin

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
2016-02-29
Primary Completion
2016-03-31
Completion
2016-04-30

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 NCT02857946 on ClinicalTrials.gov