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

To Determine Bioequivalence Under Fed Conditions Clinical Trial

Official title:
Randomized, Open Label, Two-sequence, Two-treatment, Two-period, Crossover, Single Dose Bioequivalence Study Fixed-dose Combination of Metformin and Vildagliptin Tablets 1000/50 mg Manufactured by Oman Pharmaceuticals Products Co. LLC, Sultanate of Oman, With EUCREAS® 50/1000 mg Tablets Manufactured by Novartis Pharma GmbH, Germany, in Normal, Healthy, Adult, Male Human Subjects Under Fed Conditions.

Status Completed

Clinical Trial Summary

To evaluate and compare the relative bioavailability and therefore the bioequivalence of fixed dose combination of Metformin and Vildagliptin Tablets 1000/50 mg manufactured by Oman Pharmaceuticals Products Co. LLC, Sultanate of Oman, with EUCREAS® 50/1000 mg tablets manufactured by Novartis Pharma GmbH, Germany, in Normal, Healthy, Adult, Male Human Subjects under Fed Conditions.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Disease
Malnutrition
To Determine Bioequivalence Under Fed Conditions

Clinical Trial Details

NCT number	NCT05329857
Study type	Interventional
Source	Alfred E. Tiefenbacher (GmbH & Co. KG)
Contact
Status	Completed
Phase	N/A
Start date	December 2015
Completion date	March 2016

View Details

See also
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