Trial Profile

An Oral Single-dose, Randomized, Balanced, Open-label, Two-sequence, Two-treatment, Two-period, Crossover Bioequivalence Study of Sitagliptin Hydrochloride / Metformin Hydrochloride Extended-release Film Coated Tablets 50 mg / 500 mg (FDC) of Galenicum Health S.L.U., Spain With That of JANUMET® XR (Sitagliptin Phosphate / Metformin Hydrochloride) Extended-release Coated Tablets 50 mg / 500 mg (FDC) of Merck Sharp & Dohme Pharmaceuticals Ltd., Brasil in Healthy Adult Male and Female Subjects Under Fasting Conditions.

Status: Completed

Phase of Trial: Phase I

Latest Information Update: 14 Nov 2023

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