Clinical trial NCT02171546 (phase 1, status: terminated)
Conditions: healthy
ICD codes: Z76.3, Z76.2
Drugs: dabigatran etexilate capsules, quinidine sulfate tablets, fexofenadine tablets
SMILES: CCCCCCOC(=O)\N=C(\N)C1=CC=C(NCC2=NC3=C(C=CC(=C3)C(=O)N(CCC(=O)OCC)C3=NC=CC=C3)N2C)C=C1, [H][C@@]12CCN(C[C@@H]1C=C)[C@]([H])(C2)[C@@H](O)C1=C2C=C(OC)C=CC2=NC=C1, CC(C)(C(O)=O)C1=CC=C(C=C1)C(O)CCCN1CCC(CC1)C(O)(C1=CC=CC=C1)C1=CC=CC=C1
Eligibility criteria:

        Inclusion Criteria:

          1. Healthy males and females according to the following criteria: Based upon a complete
             medical history, including the physical examination, vital signs (BP, PR), 12-lead
             ECG, clinical laboratory tests ;

          2. Age ≥18 and Age ≤55 years;

          3. Body Mass Index (BMI) ≥18.5 and BMI <30 kg/m2;

          4. Signed and dated written informed consent prior to admission to the study in
             accordance with GCP and the local legislation;

          5. If female of child-bearing potential, not be pregnant or breast feeding, nor plan to
             become pregnant for the duration of the study and for 2 months after receiving the
             last dose of study drug, and have a negative serum pregnancy test within 14 days of
             treatment, and prior to dosing;

          6. Females of child-bearing potential willing to use adequate contraception, defined as
             the use of hormonal (oral, injectable or implantable) or barrier method
             contraceptives, intrauterine device and agree to use the same method of contraception
             for at least 2 months after drug administration. Women who have undergone a total
             hysterectomy, have a history of bilateral tubal ligation or are at least 2 years
             post-menopausal are not considered to be of child-bearing potential.

        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/hypersensitivity (including allergy to drug or its
             excipients);

          9. Intake of drugs with a long half-life (>24 hours) within at least one month or less
             than 10 half-lives of the respective drug prior to administration or during the trial;

         10. Use of drugs which might reasonably influence the results of the trial or that prolong
             the QT/QTc interval based on the knowledge at the time of protocol preparation within
             10 days prior to administration or during the trial;

         11. Participation in another trial with an investigational drug within two months prior to
             administration or during the trial;

         12. Smoker (>10 cigarettes or >3 cigars or >3 pipes/day);

         13. Inability to refrain from smoking on trial days;

         14. Alcohol abuse (more than 60 g/day);

         15. Drug abuse;

         16. Blood donation (more than 100 mL within four weeks prior to administration or during
             the trial);

         17. Excessive physical activities (within one week prior to administration or during the
             trial);

         18. Any laboratory value outside the reference range that is of clinical relevance;

         19. Inability to comply with dietary regimen of trial site;

         20. A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a
             QTc interval >450 ms);

         21. A history of additional risk factors for Torsades de Pointes (e.g., heart failure,
             hypokalemia, family history of Long QT Syndrome);

         22. Taking drugs which are known P-gp inhibitors or inducers (verapamil, phenothiazine
             antipsychotics, erythromycin, antifungal drugs or St. John´s Wort) within the last 4
             weeks before screening;

         23. Chronic use of oral contraception containing ethinyl estradiol as the only method of
             contraception.