Bioequivalence Study of Empagliflozin 25 mg Film Coated Tablets of Humanis, Turkey and Jardiance (Empagliflozin) 25 mg Film-coated Tablets of Boehringer Ingelheim International GmbH, Germany in Normal, Healthy, Adult, Human Subjects Under Fasting Condition

Sponsor
Humanis Saglık Anonim Sirketi
Study ID
NCT06180109
Phase
PHASE1
Status
Completed

Conditions

  • Type2 Diabetes Mellitus

Eligibility Criteria

Sex
ALL
Age
18 Years - 45 Years
Healthy Volunteers
Accepted

Interventions

  • Empagliflozin film coated tablets — DRUG
    1 film coated tablet of 25 mg Empagliflozin
  • Jardiance film-coated tablets — DRUG
    1 film coated tablet of 25 mg Empagliflozin

Study Details

An open-label, balanced, randomized, two treatment, two sequence, two period, two way cross-over, single oral dose bioequivalence study of Empagliflozin 25 mg film coated tablets of Humanis, Turkey and Jardiance (Empagliflozin) 25 mg film-coated tablets of Boehringer Ingelheim International GmbH, Germany in normal, healthy, adult, human subjects under fasting condition.

Key Dates

Start date
Jul 30, 2023
Status verified
Dec 2023
Primary completion
Aug 27, 2023
Completion
Oct 6, 2023

Study Design

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

Arms

  • Experimental: Empagliflozin film coated tablets
    Empagliflozin 25 mg film coated tablets
  • Active Comparator: Jardiance film-coated tablets
    Jardiance (Empagliflozin) 25 mg film-coated tablets

Primary Outcome Measure

Maximum concentration obtained (Cmax) [ Time Frame: 48 hours ]

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