Completed NA INTERVENTIONAL 2-arm NCT05329844

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.

Randomized, Open Label, Two-sequence, Two-treatment, Two-period, Crossover, Single Dose Bioequivalence Study of Vildagliptin Tablets 50 mg of AET Laboratories Pvt. Ltd., India With Galvus 50 mg Tablets of Novartis Europharm Ltd., United Kingdom in Normal Healthy, Adult, Male Human Subjects Under Fasting Conditions.

Sponsor: AET Laboratories Private Limited

Conditions Diabetes Mellitus

Interventions Vildagliptin 50 MG

Updated 3 times since 2022 Last updated: Apr 14, 2022 Started: Feb 28, 2014 Primary completion: Mar 31, 2014 Completion: Apr 30, 2015

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT05329844, this NA trial focuses on Diabetes Mellitus and remains completed. Sponsored by AET Laboratories Private Limited, it has been updated 3 times since 2014, reflecting limited change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Status Flow

Change History

3 versions recorded

Sep 2024 — Present [monthly]

Completed NA
Jul 2024 — Sep 2024 [monthly]

Completed NA
May 2022 — Jul 2024 [monthly]

Completed NA

First recorded

Feb 2014

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

AET Laboratories Private Limited

Data source: Alfred E. Tiefenbacher (GmbH & Co. KG)

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

No location information available.