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
Abstract
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.
Conditions: To Determine Bioequivalence Under Fed Conditions.
Primary outcome: Cmax of Vildagliptin and Metformin for the test and reference products; AUC0-t of Vildagliptin and Metformin for the test and the reference products.
Enrollment: 60 participants.
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 60 participants or records.
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