Bioequivalence Study to Compare Empagliflozin / Metformin 25 mg/ 1000 mg Extended-Release Tablet Versus Synjardy XR Tablets 25mg/1000mg in Fast Condition

Sponsor
Humanis Saglık Anonim Sirketi
Study ID
NCT07372118
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

Bioequivalence Study to Compare Empagliflozin / Metformin 25 mg/ 1000 mg Extended-Release Tablet Versus Synjardy XR Tablets 25mg/1000mg in fast condition.

Key Dates

Start date
Sep 27, 2025
Status verified
Jan 2026
Primary completion
Dec 29, 2025
Completion
Jan 7, 2026

Study Design

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

Arms

  • Experimental: Empagliflozin / Metformin HCl XR Tablets
    Empagliflozin / Metformin HCl XR 25 mg/ 1000 mg Tablets
  • Active Comparator: Synjardy® XR (empagliflozin and metformin hydrochloride extended-release Tablets)
    Synjardy® XR (empagliflozin and metformin hydrochloride extended-release Tablets) 25 mg/1000 mg

Primary Outcome Measure

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

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