Prospective, longitudinal, single-dose, randomized, open-label, crossover 2x2, two treatments, two periods, two sequences controlled clinical study
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
42
Reference
Axis Clinicals Latina, S.A. de C.V.
Mexico City, Mexico City, Mexico
Bioequivalence based on the pharmacokinetic parameter: Cmax
Bioequivalence based on the pharmacokinetic parameter: Cmax
Time frame: Through 48 Hours Post Dose
Bioequivalence based on the pharmacokinetic parameter: AUC0-t
Bioequivalence based on the pharmacokinetic parameter: AUC0-t
Time frame: Through 48 hours Post Dose
Characterize the pharmacokinetic parameter: AUC0-inf
Characterize the pharmacokinetic parameter: AUC0-inf
Time frame: Through 48 Hours Post Dose
Characterize the pharmacokinetic parameter: time to maximum concentration (tmax)
Characterize the pharmacokinetic parameter: time to maximum concentration (tmax)
Time frame: Through 48 Hours Post Dose
Characterize the pharmacokinetic parameter: elimination constant (Ke)
Characterize the pharmacokinetic parameter: elimination constant (Ke)
Time frame: Through 48 Hours Post Dose
Characterize the pharmacokinetic parameter: half-life (t1/2)
Characterize the pharmacokinetic parameter: half-life (t1/2)
Time frame: Through 48 Hours Post Dose
Establish the frequency, severity, and seriousness of adverse events that occurred during the study.
Establish the frequency, severity, and seriousness of adverse events that occurred during the study.
Time frame: Until the final visit (14 days after the last dose)
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