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Bioequivalence Study to Compare Empagliflozin/Linagliptin/Metformin HCL 25mg/5mg/1000mg Extended-Release Tablets Versus Trijardy® XR Extended Release Film Coated Tablets

NCT07213895 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2025-10-09

No results posted yet for this study

Summary

Randomized, Single Oral Dose, Two-period, Two Sequence, Open-label, Crossover, Bioequivalence Study to Compare Empagliflozin-Linagliptin-Metformin XR Tablet 25mg/ 5mg/1000mg (25mg Empagliflozin /5mg Linagliptin /1000mgMetformin Hydrochloride) Versus Trijardy® XR Tablets (25mg Empagliflozin /5mg Linagliptin /1000mg Metformin Hydrochloride), in Healthy Subjects Under Fed Conditions.

Conditions

  • Type 2 Diabetes Mellitus (T2DM)

Interventions

DRUG

Empagliflozin/Linagliptin/Metformin HCL

One Empagliflozin/Linagliptin/Metformin HCL 25mg/5mg/1000mg extended release film-coated tablet

DRUG

Trijardy® XR Extended release film coated tablets

One Trijardy® 25mg/5mg/1000mg Extended Release 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
2025-05-21
Primary Completion
2025-09-15
Completion
2025-09-18

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 NCT07213895 on ClinicalTrials.gov