Bioequivalence Study in Healthy Volunteers for Empagliflozin/Metformin Fixed Dose Combination Compared to Separate Tablets
Condition: Healthy
Intervention: Empagliflozin 2.5 mg; Empagliflozin 10 mg; Metformin 500 mg; Empagliflozin/Metformin FDC
Intervention description: Empagliflozin 2.5 mg tablet; Empagliflozin 10 mg tablet; Metformin 500 mg tablet; 12.5 mg Empagliflozin / 500 mg Metformin
Intervention MeSH terms: Metformin; Empagliflozin
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 32.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The trial is being conducted to establish the bioequivalence of emp/met (12.5mg/500mg) fixed
      dose combination tablets compared to tablets administered together in healthy male and female
      volunteers under fed conditions.
    

Eligibility criteria:

        Inclusion criteria:

          1. Healthy males or females according to the investigator's assessment, as based on the
             following criteria: a complete medical history including a physical examination, vital
             signs (BP, PR), 12-lead ECG and clinical laboratory tests.

          2. Age 18 to 50 years (inclusive)

          3. BMI 18.5 to 29.9 kg/m2 (inclusive)

          4. Signed and dated written informed consent prior to admission to the study in
             accordance with Good Clinical Practice (GCP) and local legislation.

        Exclusion criteria:

          1. Any finding in the medical examination (Including blood pressure [BP], pulse rate
             [PR], or electrocardiogram [ECG]) deviating from normal and judged clinically relevant
             by the investigator.

          2. Any evidence of a concomitant disease judged clinically relevant by the investigator.

          3. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic,
             immunological or hormonal disorders.

          4. Surgery of the gastrointestinal tract that could interfere with kinetics of the study
             drug(s)

          5. Diseases of the central nervous system (such as epilepsy), other neurological
             disorders or psychiatric disorders.

          6. History of relevant orthostatic hypotension, fainting spells, or blackouts.

          7. Chronic or relevant acute infections

          8. History of relevant allergy/hypersensitivity (including allergy to the trial
             medication or it's excipients)

          9. 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.

         10. Within 14 days prior to the administration of trial medication, use of drugs that
             might reasonably influence the results of the trial, based on current knowledge

         11. Participation in another trial with investigational drug administration within 60 days
             prior to administration of trial medication.

         12. Smoker (has used tobacco or nicotine-containing products within 6 months prior to
             administration of trial medication)

         13. Inability to refrain from smoking on specified trial days

         14. Alcohol abuse (consumption of more than 20g/day in females and 30g/day in males or > 7
             alcohol-containing drinks per week)

         15. Drug abuse or positive drug screen

         16. Blood donation (more than 100 ml wihtin 30 days prior to administration of trial
             medication or intended during the trial)

         17. Intention to perform excessive physical activities within one week prior to
             administration of trial medication or during the trial

         18. Inability to comply with dietary regimen of trial site

         19. 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.

             For female subjects:

         20. Positive pregnancy test, pregnancy or plans to become pregnant within 30 days after
             study completion.

         21. No adequate contraception during the study and until 1 month after study completion,
             i.e. not any of the following: implants, injectables, combined oral contraceptives,
             IUD (intrauterine device), sexual abstinence for at least 1 month prior to enrolment,
             vasectomised partner (vasectomy performed at least 1 year prior to enrolment), or
             surgical sterilisation (including hysterectomy). Females, who do not have a
             vasectomised partner, are not sexually abstinent, surgically sterile, or post
             menopausal will be asked to use an additional barrier method (e.g. condom, diaphragm
             with spermicide). Post-menopausal is defined as at least 1 year of spontaneous
             amenorrhea and deemed post menopausal by a physician based on screening clinical
             laboratory tests (follicle stimulating hormone and luteinizing hormone).

         22. Lactation