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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
60
50 mg Vildagliptin + 1000 mg Metformin as single-dose per study period
Cmax of Vildagliptin and Metformin for the test and reference products
The maximum concentration in plasma among observed concentrations at pre-specified time points
Time frame: up to 24 hours
AUC0-t of Vildagliptin and Metformin for the test and the reference products
The area under the plasma concentration versus time curve from time 0 to the last measured concentration
Time frame: up to 24 hours
AUC0-∞ of Vildagliptin and Metformin for the test and the reference products
The area under the plasma concentration versus time curve from time 0 to to infinite time
Time frame: up to 24 hours
Tmax of Vildagliptin and Metformin for the test and the reference products
The time to maximum measured plasma concentration
Time frame: up to 24 hours
T1/2 of Vildagliptin and Metfomin for the test and the reference products
Plasma elimination half-life
Time frame: up to 24 hours
Kel of Vildagliptin and Metformin for the test and the reference products
Elimination rate constant
Time frame: up to 24 hours
Number of treatment-related adverse events (AE) for the test and the reference products as assessed by guidance predefined in the protocol
An AE is defined as any untoward medical occurrence in a subject administered the test or the reference product and which does not necessarily have a causal relationship with the treatment.
Time frame: through study completion, an average of 1 month
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