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

NCT07266766 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-12-05

No results posted yet for this study

Summary

An Open Label, Balanced, Randomized, Single dose, Two treatment, Two sequence, Two period, two way crossover, Oral Bioequivalence Study of test product of Empagliflozin / Metformin 25 mg/ 1000 mg Extended-Release Tablet and Reference product of Synjardy XR tablets 25mg/1000mg in Healthy, adult, human Subjects Under fed Condition.

Conditions

  • Type 2 Diabetes Mellitus (T2DM)

Interventions

DRUG

Empagliflozin / Metformin HCl XR Tablets

One Empagliflozin / Metformin HCl XR 25 mg/ 1000 mg Tablets

DRUG

Synjardy® XR (empagliflozin and metformin hydrochloride extended-release Tablets)

One Synjardy® XR (empagliflozin and metformin hydrochloride extended-release Tablets) 25 mg/1000 mg

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
No

Timeline & Regulatory

Start
2025-08-05
Primary Completion
2025-09-24
Completion
2025-10-06

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 NCT07266766 on ClinicalTrials.gov