Bioequivalence of a Fixed Dose Combination Tablet of Empagliflozin/Linagliptin Compared With the Free Combination of Empagliflozin Tablet and Linagliptin Tablet in Healthy Male and Female Subjects
Condition: Healthy
Intervention: Empagliflozin; Linagliptin
Intervention MeSH terms: Empagliflozin; Linagliptin
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 56.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The primary objective of this trial is to investigate the bioequivalence of one fixed dose
      combination tablet of empagliflozin/linagliptin (Test, T) compared with the free combination
      of one empagliflozin tablet and one linagliptin tablet (Reference, R) administered as single
      dose under fasted conditions.
    

Eligibility criteria:

        Inclusion criteria:

          -  Healthy male or female subjects according to the investigators assessment, 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 GCP (Good Clinical Practice) and local legislation

          -  Male subjects, or female subjects who meet any of the following criteria starting from
             at least 30 days before the first administration of trial medication and until 30 days
             after trial completion:

          -  Use of adequate contraception, e.g. any of the following methods plus condom:
             implants, injectables, combined oral or vaginal contraceptives, intrauterine device

          -  Sexually abstinent

          -  A vasectomised sexual partner (vasectomy at least 1 year prior to enrolment)

          -  Surgically sterilised (including hysterectomy)

          -  Postmenopausal, defined as at least 1 year of spontaneous amenorrhea (in questionable
             cases a blood sample with simultaneous levels of FSH (Follicle Stimulating Hormone)
             above 40 U/L and estradiol below 30 ng/L is confirmatory)

        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 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