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

Sponsor
Humanis Saglık Anonim Sirketi
Study ID
NCT07213895
Phase
PHASE1
Status
Completed

Conditions

  • Type 2 Diabetes Mellitus (T2DM)

Eligibility Criteria

Sex
ALL
Age
18 Years - 50 Years
Healthy Volunteers
Accepted

Interventions

  • Empagliflozin/Linagliptin/Metformin HCL — DRUG
    One Empagliflozin/Linagliptin/Metformin HCL 25mg/5mg/1000mg extended release film-coated tablet
  • Trijardy® XR Extended release film coated tablets — DRUG
    One Trijardy® 25mg/5mg/1000mg Extended Release Tablets

Study Details

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.

Key Dates

Start date
May 21, 2025
Status verified
Oct 2025
Primary completion
Sep 15, 2025
Completion
Sep 18, 2025

Study Design

Enrollment
14 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER

Arms

  • Experimental: Empagliflozin/Linagliptin/Metformin HCL Extended Release Tablets
    Empagliflozin/Linagliptin/Metformin HCL 25mg/5mg/1000mg Extended Release Tablets
  • Active Comparator: Trijardy® XR Extended release film coated tablets
    Trijardy® 25mg/5mg/1000mg Extended release film coated tablets

Primary Outcome Measure

For Empagliflozin & Linagliptin & Metformin; Maximum concentration obtained (Cmax) [ Time Frame: 72 hours ]

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