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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
66
50 mg Vildagliptin as single-dose per study period
Cmax of Vildagliptin 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 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 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 for the test and the reference products
The time to maximum measured plasma concentration
Time frame: up to 24 hours
T1/2 of Vildagliptin for the test and the reference products
Plasma elimination half-life
Time frame: up to 24 hours
Kel of Vildagliptin 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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