clinical trial · NCT07633015
CLINICAL STUDY TO DETERMINE BIOEQUIVALENCE BETWEEN TWO ORAL MEDICATIONS OF EMPAGLIFLOZIN/METFORMIN IN 5 mg / 850 mg TABLETS UNDER FED CONDITIONS.
ADIUM·N/A·completed·n = 42
Bioequivalence Study in Healthy SubjectsTest. Empagliflozin/metformin 5/850 mgSynjardy 5/850 mg tablet, Reference
brief summary
Prospective, longitudinal, single-dose, randomized, open-label, crossover 2x2, two treatments, two periods, two sequences controlled clinical study
started
Feb 17, 2025
primary completion
Apr 29, 2025
completion
Apr 29, 2025
last updated
Jun 8, 2026
detailed description
The study design was a randomized, open-label, two-way, crossover, single-dose, prospective, and longitudinal study, with a 14-day wash-out period before next dosing; to compare the pharmacokinetic profile (Cmax and AUC0-t) of two 5/ 850 mg empagliflozin/metformin FDC tablet in forty-two (42) healthy Mexican adult volunteers aged 18 to 55 years.
official title
CLINICAL STUDY TO DETERMINE BIOEQUIVALENCE BETWEEN TWO ORAL MEDICATIONS OF EMPAGLIFLOZIN/METFORMIN IN 5 mg / 850 mg TABLETS IN HEALTHY SUBJECTS UNDER FED CONDITIONS.
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol