Pharmacokinetics of BI 409306 After a High Fat, High Caloric Meal and After a Single Oral Dose Given at Bed Time in Healthy Volunteers

Launched by BOEHRINGER INGELHEIM · Aug 20, 2014

Keywords

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Gender

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Eligibility criteria

• Inclusion criteria:
• • 1. Healthy male and female volunteers
• • 2. Age 18 (incl.) to 50 (incl.) years
• • 3. Body mass index (BMI) range: 18.5 (incl.) to 29.9 (incl.) kg/m2
• Exclusion criteria:
• • 1. Any evidence of a clinically relevant concomitant disease
• • 2. Any finding of the medical examination (including BP, PR and ECG) deviating from normal and of clinical relevance
• • 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 (including but not limited to any kind of seizures, stroke or psychiatric disorders)
• • 6. History or evidence of relevant orthostatic reaction, fainting spells or blackouts, occurrence of syncopes, brady- or tachycardia in the anamnesis.
• • 7. Positive pregnancy test
• • 8. No adequate contraception during the study and until 1 month of study completion, i.e. intrauterine device (IUD), sexual abstinence (for at least 1 month prior to enrolment), or surgical sterilisation (incl. hysterectomy). Females, who are not surgically sterile will be asked to additionally use barrier contraception methods (e.g. condom, diaphragm with spermicide)