Vildagliptin 50 mg
Drug50 mg Vildagliptin as single-dose per study period
NCT Number: NCT05329844
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.
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Notify Me18 year–45 year
Male
Interventional
Not applicable
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
50 mg Vildagliptin as single-dose per study period
Time frame: up to 24 hours
The maximum concentration in plasma among observed concentrations at pre-specified time points
Time frame: up to 24 hours
The area under the plasma concentration versus time curve from time 0 to the last measured concentration
Time frame: up to 24 hours
The area under the plasma concentration versus time curve from time 0 to to infinite time
Time frame: up to 24 hours
The time to maximum measured plasma concentration
Time frame: up to 24 hours
Plasma elimination half-life
Time frame: up to 24 hours
Elimination rate constant
Time frame: through study completion, an average of 1 month
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.
AET Laboratories Private Limited
Industry
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.
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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