Metformin and Vildagliptin 1000/50 mg
Drug50 mg Vildagliptin + 1000 mg Metformin as single-dose per study period
NCT Number: NCT05329857
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.
Looking for future studies?
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 + 1000 mg Metformin 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 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.
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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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