Relative Bioavailability of Two Different Batches of a Linagliptin / Metformin Combination Tablet in Healthy Volunteers
Condition: Healthy
Intervention: Linagliptin/Metformin (standard batch); Linagliptin/Metformin (side batch)
Intervention description: Fixed dose combination tablet; Fixed dose combination tablet
Intervention MeSH terms: Metformin; Linagliptin
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 40.0
Sex: All
Minimum age: 21 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The objective of the current study is to investigate the relative bioavailability of two
      different batches of a 2.5 mg linagliptin / 1000 mg metformin fixed dose combination tablet
      (FDC).
    

Eligibility criteria:

        Inclusion criteria:

          1. Healthy males and females according to the following criteria: Based upon a complete
             medical history, including physical examination, vital signs (blood pressure (BP),
             pulse rate (PR)), 12-lead electrocardiogram (ECG), clinical laboratory tests

          2. Age 21 to 50 years (incl.)

          3. Body Mass Index (BMI) 18.5 to 29.9 kg/m2 (incl.)

          4. Signed and dated written informed consent prior to admission to the study in
             accordance with Good Clinical Practice (GCP) and the local legislation

        Exclusion criteria:

          1. Any finding of the medical examination (including BP, PR and ECG) deviating from
             normal and of clinical relevance

          2. Any evidence of a clinically relevant concomitant disease

          3. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic,
             immunological or hormonal disorders

          4. Surgery of the gastrointestinal tract (except appendectomy)

          5. Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or
             neurological disorders

          6. History of relevant orthostatic hypotension, fainting spells or blackouts

          7. Chronic or relevant acute infections

          8. History of relevant allergy or hypersensitivity (including allergy to drug or its
             excipients)

          9. Intake of drugs within one month or less than 10 half-lives of the respective drug
             prior to first study drug administration

         10. Participation in another trial with an investigational drug within 2 months prior to
             administration or during the trial

         11. Smoker (more than 10 cigarettes or 3 cigars 3 pipes daily)

         12. Alcohol abuse (average consumption of more than 20 g/day in females and 30 g/day in
             males)

         13. Drug abuse

         14. Blood donation (more than 100 mL within four weeks prior to day 1 of visit 2)

         15. Any laboratory value outside the reference range that is of clinical relevance

         16. Inability to comply with dietary regimen of trial site

             For female subjects of childbearing potential only:

         17. Positive pregnancy test, pregnancy or planning to become pregnant 1 month before study
             or within 2 months after study completion

         18. No adequate contraception 1 month before study and until 2 month after study
             completion, e.g. not any of the following: implants, injectables, combined hormonal
             contraceptives, hormonal IUD (intrauterine device), sexual abstinence for at least 1
             month prior to first study drug administration, 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 or surgically sterile will be asked to use an additional barrier method
             (e.g. condom).

         19. Lactation