The Study Aims 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 Assessed.

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 850/ 50 mg Manufactured by Oman Pharmaceuticals Products Co. LLC, Sultanate of Oman, With EUCREAS® 50/850mg 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 850/50 mg manufactured by Oman Pharmaceuticals Products Co. LLC, Sultanate of Oman, with EUCREAS® 50/850mg 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	NCT05337969
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
Status	Clinical Trial	Phase
Completed	`NCT00652600` - Bioavailability Study of Propranolol Under Fed Conditions	Phase 1
Completed	`NCT01380496` - Bioequivalence Study of Doxycycline Monohydrate Tablets Under Fed Conditions	Phase 1
Completed	`NCT00652821` - Bioavailability Study of Tramadol/APAP Tablets Under Fed Conditions	Phase 1
Completed	`NCT00652873` - Bioequivalence Study of Cabergoline Tablets and Dostinex Under Fed Conditions	Phase 1
Completed	`NCT00652704` - Bioavailability Study of Doxycycline Monohydrate Capsules and Monodox Under Fasting and Fed Conditions	Phase 1
Completed	`NCT00652730` - Bioavailability Study of (Buspar) Buspirone HCl Tablets Under Fasting and Fed Conditions	Phase 1
Completed	`NCT05329857` - 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.	N/A
Completed	`NCT00653003` - Bioavailability Study of Leflunomide Tablets Under Fed Conditions	Phase 1
Completed	`NCT01380431` - A Comparative Bioavailability Study of Lisinopril Tablets, 40 mg - Effect of Food Study	Phase 1