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Bioequivalence Study to Compare Empagliflozin + Linagliptin 25 mg/5 mg Film-coated Tablets Versus Glyxambi 25 mg/ 5 mg Film-coated Tablets

NCT06932159 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-04-17

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 in healthy, adult, human subjects under fasting condition.

Conditions

  • Type 2 Diabetes Mellitus (T2DM)

Interventions

DRUG

Empagliflozin + Linagliptin film-coated tablets

1 tablet of Empagliflozin + Linagliptin 25 mg/5 mg film-coated tablets

DRUG

Glyxambi film-coated tablets

1 tablet of Glyxambi 25 mg/ 5 mg 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
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-12-23
Primary Completion
2025-03-07
Completion
2025-04-08

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 NCT06932159 on ClinicalTrials.gov