Bioequivalence Study of Empagliflozin 25 mg Film-coated Tablets in Healthy Thai Volunteers

Sponsor
International Bio service
Study ID
NCT06337409
Phase
PHASE1
Status
Unknown

Conditions

  • Healthy Volunteer

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

Study Details

To determine and compare the rate and extent of absorption of a test formulation with that of a reference innovator formulation when given as equal labeled dose in healthy subjects under fasting conditions

Key Dates

Start date
Jul 1, 2024
Status verified
Mar 2024
Primary completion
Jul 5, 2024
Completion
Jul 13, 2024

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER

Arms

  • Experimental: Empagliflozin 25 mg film-coated tablets
    The test product, generic empagliflozin 25 mg film-coated tablets, will be formulated using the same active ingredient with the same strength as the reference product, JARDIANCE®. The test product to be used in this bioequivalence study is prepared in accordance with GMP regulations.
  • Active Comparator: Empagliflozin 25 mg film-coated tablets, JARDIANCE
    Empagliflozin 25 mg film-coated tablets, JARDIANCE®, has been registered with Food and Drug Administration, Thailand (TFDA).

Primary Outcome Measure

Bioequivalence based on Cmax period [ Time Frame: Through 72 Hours Post Dose ]

Central Contacts

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