This Study in Healthy People Tests Whether Taking a Low Strength of Empagliflozin, Linagliptin, and Metformin Together in 1 Pill is the Same as Taking Them in Separate Pills
Condition: Healthy
Intervention: Empagliflozin, Metformin HCl, Linagliptin (fixed dose combination); Empagliflozin; Linagliptin; Metformin HCl
Intervention description: single dose; single dose; single dose; single dose
Intervention MeSH terms: Metformin; Empagliflozin; Linagliptin
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The primary objective of this trial is to establish the bioequivalence of two
      empagliflozin/linagliptin/metformin extended release (XR) fixed dose combination (FDC)
      tablets (Test, T) compared with the same doses of the individual components given in separate
      tablets (Reference, R) when administered together after a high-fat, high-calorie meal.

      The assessment of safety and tolerability will be the secondary objective of this trial.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy male or female subjects according to the assessment of the investigator, based
             on a complete medical history including a physical examination, vital signs (Blood
             pressure (BP), Pulse rate (PR)), 12-lead Electrocardiogram (ECG), and clinical
             laboratory tests

          -  Age of 18 to 55 years (incl.)

          -  Body mass index (BMI) of 18.5 to 29.9 kg/m2 (incl.)

          -  Signed and dated written informed consent prior to admission to the study in
             accordance with Good Clinical Practice (GCP) and local legislation

          -  Female subjects of childbearing potential willing to use adequate contraception.

          -  Further inclusion criteria apply

        Exclusion criteria:

          -  Any finding in the medical examination (including Blood pressure (BP), Pulse rate (PR)
             or Electrocardiogram (ECG)) is deviating from normal and judged as clinically relevant
             by the investigator

          -  Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg,
             diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the
             range of 45 to 90 beats per minute (bpm)

          -  Any laboratory value outside the reference range that the investigator considers to be
             of clinical relevance

          -  Any evidence of a concomitant disease judged as clinically relevant by the
             investigator

          -  Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic,
             immunological or hormonal disorders

          -  Cholecystectomy and/or surgery of the gastrointestinal tract that could interfere with
             the pharmacokinetics of the trial medication (except appendectomy and simple hernia
             repair)

          -  Diseases of the central nervous system (including but not limited to any kind of
             seizures or stroke), and other relevant neurological or psychiatric disorders

          -  Further exclusion criteria apply