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

Sponsor
Humanis Saglık Anonim Sirketi
Study ID
NCT07266766
Phase
PHASE1
Status
Completed

Conditions

  • Type 2 Diabetes Mellitus (T2DM)

Eligibility Criteria

Sex
ALL
Age
18 Years - 45 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

An Open Label, Balanced, Randomized, Single dose, Two treatment, Two sequence, Two period, two way crossover, Oral Bioequivalence Study of test product of Empagliflozin / Metformin 25 mg/ 1000 mg Extended-Release Tablet and Reference product of Synjardy XR tablets 25mg/1000mg in Healthy, adult, human Subjects Under fed Condition.

Key Dates

Start date
Aug 5, 2025
Status verified
Oct 2025
Primary completion
Sep 24, 2025
Completion
Oct 6, 2025

Study Design

Enrollment
40 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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