A Study in Healthy Humans to Assess the Relative Bioavailability of One Fixed-dose Combination Tablet Empagliflozin/Metformin Versus Jardiance® Tablet and Glifage® Tablet Administered Together
Condition: Healthy
Intervention: FDC 12.5mg empagliflozin/850mg metformin; Empagliflozin; Glifage®
Intervention description: empagliflozin/metformin; empagliflozin 10mg (R1); Glifage® 850mg (R2)
Intervention MeSH terms: Metformin; Empagliflozin
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Masking description: The bioanalytical staff involved are blinded to treatment
Enrollment: 32.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This trial is to establish bioequivalence of the fixed dose combination (FDC) tablets
      (containing 12.5 mg empagliflozin/850 mg metformin) (Test, T) compared with the single
      tablets (10 mg empagliflozin and Glifage® 850 mg tablets) (Reference, R).
    

Eligibility criteria:

        Inclusion criteria:

          -  Healthy male or female subjects according to the assessment of the investigator, as
             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 at least 18 (inclusive) to 50 years (inclusive)

          -  Body mass index (BMI) of 18.5 to 29.9 weight divided by height squared (kg/m2)
             (inclusive)

          -  Signed and dated written informed consent prior to admission to the study, in
             accordance with Good Clinical Practice (GCP) and local legislation

          -  Male subjects, or female subjects who meet any of the following criteria from at least
             30 days before the first administration of trial medication 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)

        Exclusion Criteria:

          -  Any finding in the medical examination (including BP, PR or ECG) deviating from normal
             and assessed as clinically relevant by the investigator

          -  Repeated measurement of systolic blood pressure outside the range of 90 to 140
             millimetre of mercury (mmHg), diastolic blood pressure outside the range of 50 to 90
             mmHg, or pulse rate outside the range of 50 to 90 beats per minute (bpm)

          -  Any laboratory value outside the reference range that the investigator considers to be
             of clinical relevance

          -  Cholecystectomy or other surgery of the gastrointestinal tract that could interfere
             with the pharmacokinetics of the trial medication (except appendectomy or simple
             hernia repair)

          -  History of relevant orthostatic hypotension, fainting spells, or blackouts

          -  Chronic or relevant acute infections

          -  Use of drugs within 30 days of planned administration of trial medication that might
             reasonably influence the results of the trial (including drugs that cause time from
             the start of the Q wave to the end of the T wave (QT) / corrected QT (QTc) interval
             prolongation)

          -  Smoker (more than 5 cigarettes or 1 cigar or 1 pipe per day)

          -  Detection or indeterminate / inconclusive result of the severe acute respiratory
             syndrome coronavirus 2 (SARS-CoV-2) Coronavirus ribonucleic acid (RNA) in the
             quantitative real-time polymerase chain reaction (RT-qPCR) exam performed on the day
             before the admission of each period;

          -  The research participant presents symptoms of coronavirus disease 2019 (COVID-19)
             infection (even if the result is "undetected" in the RT-PCR exam for COVID-19)

          -  Further exclusion criteria apply