To Compare and Evaluate the Oral Bioavailability of Empagliflozin + Linagliptin 10 mg/5 mg Filmcoated Tablets With That of Glyxambi 10 mg/ 5 mg Film-coated Tablets in Healthy, Adult, Human Subjects Under Fasting Conditions.

Sponsor
Humanis Saglık Anonim Sirketi
Study ID
NCT07039890
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

To compare and evaluate the oral bioavailability of Empagliflozin + Linagliptin 10 mg/5 mg film-coated tablets with that of Glyxambi 10 mg/ 5 mg film-coated tablets in healthy, adult, human subjects under fasting conditions.

Key Dates

Start date
Mar 8, 2025
Status verified
Jun 2025
Primary completion
May 14, 2025
Completion
Jun 5, 2025

Study Design

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

Arms

  • Experimental: Empagliflozin + Linagliptin filmcoated tablets
    Empagliflozin + Linagliptin 10 mg/5 mg filmcoated tablets
  • Active Comparator: Glyxambi film-coated tablets
    Glyxambi 10 mg/5 mg film-coated tablets

Primary Outcome Measure

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

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