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Bioequivalence Study to Compare Empagliflozin/ Metformin 25 mg/ 1000 mg Extended-Release Tablet Versus Synjardy XR Tablets 25mg/1000mg

NCT07694115 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-07-09

No results posted yet for this study

Summary

An open label, randomized, two-period, two treatment, two-sequence, crossover, balanced, single dose oral bioequivalence study to compare Empagliflozin / Metformin 25 mg/ 1000 mg Extended-Release Tablet versus Synjardy XR tablets 25mg/1000mg in healthy subject in fasting condition.

Conditions

  • Type 2 Diabetes Mellitus (T2DM)

Interventions

DRUG

Empagliflozin / Metformin Extended-Release Tablet

1 extended Release tablet of Empagliflozin / Metformin 25 mg/ 1000 mg Extended-Release Tablet

DRUG

Synjardy XR tablets

1 extended Release tablet of Synjardy XR tablets 25mg/1000mg

Sponsors & Collaborators

  • Humanis Saglık Anonim Sirketi

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2026-05-07
Primary Completion
2026-06-29
Completion
2026-07-01

Countries

  • India

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 NCT07694115 on ClinicalTrials.gov