Identification Module
The Identification Module contains basic identifying information about the clinical trial, including the NCT ID, brief title, official title, acronym, organization study ID information, and organization details. This module provides essential identifiers for the trial.
Identification Module path is as follows:
Study -> Protocol Section -> Identification Module
Identification Module
Ignite Creation Date:
2025-12-25 @ 2:01 AM
Ignite Modification Date:
2025-12-25 @ 2:01 AM
NCT ID:
NCT06124560
Brief Title:
Bioequivalence Study of Sitagliptin Hydrochloride / Metformin Hydrochloride Extended-release Film Coated Tablets 100 mg /1000 mg (FDC) in Healthy Adult Male and Female Subjects Under Fasting Conditions.
Official Title:
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 100 mg /1000 mg (FDC) of Galenicum Health S.L.U., Spain With That of JANUMET® XR (Sitagliptin Phosphate / Metformin Hydrochloride) Extended-release Coated Tablets 100 mg / 1000 mg (FDC) of Merck Sharp & Dohme Pharmaceuticals Ltd., Brazil in Healthy Adult Male and Female Subjects Under Fasting Conditions.
Study:
NCT06124560
Protocol Section:
NCT06124560