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

Sponsor
Humanis Saglık Anonim Sirketi
Study ID
NCT06932159
Phase
PHASE1
Status
Completed

Conditions

  • Type 2 Diabetes Mellitus (T2DM)

Eligibility Criteria

Sex
ALL
Age
18 Years - 45 Years
Healthy Volunteers
Accepted

Interventions

Study Details

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.

Key Dates

Start date
Dec 23, 2024
Status verified
Dec 2024
Primary completion
Mar 7, 2025
Completion
Apr 8, 2025

Study Design

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

Arms

  • Experimental: Empagliflozin + Linagliptin film-coated tablets
    Empagliflozin + Linagliptin 25 mg/5 mg film-coated tablets
  • Active Comparator: Glyxambi film-coated tablets
    Glyxambi 25 mg/ 5 mg film-coated tablets

Primary Outcome Measure

For Empagliflozin; Peak Plasma Concentration (Cmax) [ Time Frame: 72 hours ]

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