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The Study Aims to Show Bioequivalence of the Test Product and the Reference Reference Product in a Crossover Design Study Healthy Volunteers. Additionally, the Safeyt Profile of Test Product Compared to Reference Product Will be Assessed.

NCT05329844 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2022-04-15

No results posted yet for this study

Summary

To evaluate and compare the relative bioavailability and therefore the bioequivalence of Vildagliptin Tablets 50 mg of AET Laboratories Private Limited, India, with GALVUS® 50 mg Tablets of Novartis Europharm Limited, United Kingdom, in normal, healthy, adult, male human subjects under fasting conditions and to evaluate the safety and tolerability of Vildagliptin Tablets 50 mg in normal, healthy, adult, male human subjects under fasting conditions.

Conditions

Interventions

DRUG

Vildagliptin 50 MG

50 mg Vildagliptin as single-dose per study period

Sponsors & Collaborators

  • AET Laboratories Private Limited

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2014-02-28
Primary Completion
2014-03-31
Completion
2015-04-30

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Entities

Diseases

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 NCT05329844 on ClinicalTrials.gov