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Bioequivalence Study to Compare Empagliflozin/ Metformin HCl 12.5mg/1000mg Film-coated Tablets

NCT06450262 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2024-06-10

No results posted yet for this study

Summary

Randomized, two-way, two-period, single oral dose, open-label, crossover, bioequivalence study to compare Empagliflozin/ Metformin HCl 12.5mg/1000mg film-coated tablets (12.5mg Empagliflozin / 1000mg Metformin HCl) versus Synjardy® 12.5mg/1000mg film-coated tablets (12.5mg Empagliflozin/ 1000mg Metformin HCl) in healthy subjects under fed conditions.

Conditions

  • Type2diabetes

Interventions

DRUG

Emapgliflozin/Metformin 12.5mg/1000mg Film-coated tablets

1 tablet of Emapgliflozin/Metformin 12.5mg/1000mg Film-coated tablets

DRUG

Synjardy® 12.5mg/1000mg film-coated tablets

1 tablet of Emapgliflozin/Metformin 12.5mg/1000mg Film-coated tablets

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
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-01-04
Primary Completion
2024-01-16
Completion
2024-03-05

Countries

  • Jordan

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 NCT06450262 on ClinicalTrials.gov