Demonstrate Bioequivalence of Two 12.5 mg Empagliflozin/500 mg Metformin Fixed Dose Combination Tablets With Free Combination of Empagliflozin 25 mg and Metformin 1000 mg in Healthy Male and Female Volunteers Under Fed Conditions
Condition: Healthy
MeSH terms: Malnutrition
Intervention: Empagliflozin; Metformin; Empagliflozin; Metformin
Intervention description: Test Therapy - fixed dose combination of 2 tablets of 12.5 mg Empagliflozin and 500 mg Metformin; Test Therapy - fixed dose combination of 2 tablets of 12.5 mg Empagliflozin and 500 mg Metformin; Reference Therapy - free combination of 1 tablets of 25 mg Empagliflozin and 1000 mg Metformin; Reference Therapy - free combination of 1 tablets of 25 mg Empagliflozin and 1000 mg Metformin
Intervention MeSH terms: Metformin; Empagliflozin
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 25.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Bioequivalence of two 12.5 mg empagliflozin/500 mg metformin fixed dose combination tablets
      compared to the free combination of empagliflozin 25 mg and metformin 1000 mg in healthy male
      and female volunteers under fed conditions
    

Eligibility criteria:

        Inclusion criteria:

          -  Healthy male and female subjects aged 18 to 45 years and BMI 18.50 to 24.99 kg/m2 by
             Quetelet

          -  Signed informed consent prior to admission to the study

          -  Subjects must be able to undergo all trial related requests and procedures and follow
             any trial related restrictions on concomitant medications, diet and life style

          -  Subjects must be never-smokers or ex-smokers who stopped smoking prior to enrolment
             (Visit 1)

          -  Male or female subjects using adequate contraception from at least 30 days before the
             first study drug administration and until 30 days after trial completion

        Exclusion criteria:

          -  Any finding in the medical examination (including BP, PR or ECG) deviating from normal
             and any laboratory value outside the reference range

          -  Positive results of blood tests for infections (HIV, Syphilis, Hepatitis B or C),
             urine drug screening test and alcohol breath test

          -  Any evidence of a concomitant disease judged clinically relevant by the investigator
             and presence of cardiovascular, respiratory, nervous, endocrine, reproductive,
             hematopoietic, immune system disorders; gastrointestinal, hepatic, urinary tract,
             hepatobiliary disorder, mental disturbance

          -  Surgery of the gastrointestinal tract that could interfere with kinetics of the study
             drugs (except appendectomy)

          -  History of relevant orthostatic hypotension, fainting spells, or blackouts

          -  Relevant chronic or aAcute infections/ acute diseases occurred within 4 weeks before
             inclusion into the study

          -  History of relevant allergy/hypersensitivity (including allergy to the trial
             medication or its excipients)

          -  Regular use of medicinal products less than 2 weeks before investigational drug
             administration

          -  Intake of systemic inhibitors or inductors of microsomal hepatic enzymes in less than
             30 days before investigational drug administration

          -  Intake of drugs with a long half-life (¿24 hours) within 30 days or less than 10
             half-lives of the respective drug prior to administration of trial medication

          -  Use of drugs which might reasonably influence the results of the trial based on
             current knowledge within 14 days prior to drug administration or during the trial

          -  Participation in another trial with investigational drug administration within 3
             months prior to administration of trial medication

          -  Alcohol intake = 10 units of alcohol per week (1 unit of alcohol equals one 50 ml
             single measure of distilled alcoholic beverages/spirits (ABV 40%), or 0.5 litre of
             beer (ABV 5%), or 200 ml glass or red wine (ABV 12%) or history of alcohol abuse,
             narcomania, or other drug abuse.

          -  Drug abuse

          -  Blood donation (more than 100 mL within 30 days prior to administration of trial
             medication or intended during the trial)

          -  Intention to perform excessive physical activities within one week prior to
             administration of trial medication or during the trial

          -  Inability to comply with dietary regimen as per protocol and per protocol procedures

          -  Subject is assessed by the investigator as unsuitable for inclusion, for instance,
             because considered not able to understand and comply with study requirements, or has a
             condition that would not allow safe participation in the study

          -  Intake of xanthine-containing drinks or foods and alcohol from 72 h before screening
             and second treatment period

          -  Intake of drinks or foods containing grapefruits, Chinese grapefruits, Seville oranges
             for female subjects:

          -  Positive pregnancy test, pregnancy or plans to become pregnant within 30 days after
             study completion

          -  Breast feeding