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.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 66 (actual)
• Sponsor: AET Laboratories Private Limited · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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

• Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	Vildagliptin 50 MG	50 mg Vildagliptin as single-dose per study period

Timeline

• Start date: 2014-02-01
• Primary completion: 2014-03-01
• Completion: 2015-04-01
• First posted: 2022-04-15
• Last updated: 2022-04-15