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Clinical Study to Determine Bioequivalence Between Two Oral Medications of Empagliflozin/Metformin in 12.5 mg / 500 mg Tablets Under Fed Conditions.

NCT07633054 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2026-06-10

No results posted yet for this study

Summary

Prospective, longitudinal, single-dose, randomized, open-label, crossover 2x2, two treatments, two periods, two sequences controlled clinical study

Conditions

  • Bioequivalence Study in Healthy Subjects

Interventions

DRUG

Synjardy 5/850 mg tablet, Reference

Synjardy 5/850 mg tablet, Reference

DRUG

Empagliflozin/metformin 12.5/500 mg test

Empagliflozin/metformin 12.5/500 mg test

Sponsors & Collaborators

  • ADIUM

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-09-10
Primary Completion
2025-11-24
Completion
2025-11-24

Countries

  • Mexico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07633054 on ClinicalTrials.gov