Relative Bioavailability of 2 Oral Formulations of Nintedanib
Condition: Healthy
Intervention: Nintedanib; Nintedanib; Nintedanib
Intervention description: 1 soft gelatine capsule, single dose, oral; Nintedanib, 2 soft gelatine capsules, single dose, oral
Intervention MeSH terms: Nintedanib
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 70.0
Sex: Male
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      To establish the bioequivalence of 1 soft gelatine capsule containing 200 mg nintedanib
      compared to 2 soft gelatine capsules containing 100 mg nintedanib
    

Eligibility criteria:

        Inclusion criteria:

          1. Healthy male subjects according to the investigators assessment, based on a complete
             medical history including a physical examination, vital signs (BP, PR), 12-lead ECG,
             and clinical laboratory tests.

          2. Age of 18 to 50 years (incl.)

          3. Body weight of at least 70 kg

          4. BMI of 21 to 31 kg/m2 (incl.)

          5. Signed and dated written informed consent prior to admission to the study in
             accordance with GCP and local legislation

          6. Male subjects, who are willing to use a medically acceptable method of contraception
             during the first 3 months after administration of nintedanib. Acceptable methods of
             contraception for use by male volunteers include sexual abstinence, a vasectomy
             performed at least 1 year prior to dosing and barrier contraception (condom).
             Subjects, who are not vasectomised or sexually abstinent have to ensure that an
             additional acceptable method of contraception will be used by his female partner such
             as IUD (intrauterine device), surgical sterilisation (including hysterectomy),
             hormonal contraception (e.g. implants, injectables, combined oral or vaginal
             contraceptives) that started at least 2 months prior to first nintedanib
             administration, or barrier method (e.g. diaphragm with spermicide).

        Exclusion criteria:

          1. Any finding in the medical examination (including BP, PR or ECG) is deviating from
             normal and judged as clinically relevant by the investigator

          2. Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg,
             diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the
             range of 45 to 90 bpm

          3. Any laboratory value outside the reference range that the investigator considers to be
             of clinical relevance

          4. Any evidence of a concomitant disease judged as clinically relevant by the
             investigator

          5. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic,
             immunological or hormonal disorders

          6. Cholecystectomy and/or surgery of the gastrointestinal tract that could interfere with
             the pharmacokinetics of the trial medication (except appendectomy and simple hernia
             repair)

          7. Diseases of the central nervous system (including but not limited to any kind of
             seizures or stroke), and other relevant neurological or psychiatric disorders

          8. History of relevant orthostatic hypotension, fainting spells, or blackouts

          9. Chronic or relevant acute infections

         10. History of relevant allergy or hypersensitivity (including allergy to the trial
             medication or its excipients)

         11. Intake of drugs with a long half-life (more than 24 h) within 30 days or less than 10
             half-lives of the respective drug prior to administration of trial medication

         12. Within 10 days prior to administration of trial medication, use of drugs that might
             reasonably influence the results of the trial

         13. Participation in another trial where an investigational drug has been administered
             within 60 days prior to planned administration of trial medication

         14. Smoker (more than 10 cigarettes or 3 cigars or 3 pipes per day)

         15. Inability to refrain from smoking on specified trial days

         16. Alcohol abuse (consumption of more than 30 g per day for males)

         17. Drug abuse or positive drug screening

         18. Blood donation of more than 100 mL within 30 days prior to administration of trial
             medication or intended donation during the trial

         19. Intention to perform excessive physical activities within one week prior to
             administration of trial medication or during the trial

         20. Inability to comply with dietary regimen of trial site

         21. Subject is assessed as unsuitable for inclusion by the investigator, 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