Status:
COMPLETED
Bioavailability of BI 10773 and Pioglitazone in Healthy Male Volunteers
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Healthy
Eligibility:
MALE
18-50 years
Phase:
PHASE1
Brief Summary
The objective of the study was to investigate whether there is a drug-drug interaction between BI 10773 and pioglitazone when co-administered as multiple oral doses. Therefore, the relative bioavailab...
Eligibility Criteria
Inclusion
- Healthy males according to the following criteria:
- Based upon a complete medical history, including the physical examination, vital signs (Blood Pressure (BP), Pulse Rate (PR)), 12-lead ECG (electrocardiogram), clinical laboratory tests
- Age 18 to 50 years (incl.)
- BMI 18.5 to 29.9 kg/m2 (incl.)
- Signed and dated written informed consent prior to admission to the study in accordance with GCP (Good Clinical Practice) and the local legislation
Exclusion
- Any finding of the medical examination (including BP, PR and ECG) deviating from normal and of clinical relevance
- Any evidence of a clinically relevant concomitant disease
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- Surgery of the gastrointestinal tract (except appendectomy)
- Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
- History of relevant orthostatic hypotension, fainting spells or blackouts
- Chronic or relevant acute infections
- History of relevant allergy/hypersensitivity (including allergy to drug or its excipients)
- Intake of drugs with a long half-life (more than 24 hours) within at least one month or less than 10 half-lives of the respective drug prior to administration or during the trial
- Participation in another trial with an investigational drug within two months prior to administration or during the trial
- Smoker (more than 10 cigarettes or more than 3 cigars or more than 3 pipes/day)
- Inability to refrain from smoking on trial days
- Alcohol abuse (more than 30 g/day)
- Drug abuse
- Blood donation (more than 100 mL within four weeks prior to administration or during the trial)
- Excessive physical activities (within one week prior to administration or during the trial)
- ALT (Alanine transaminase) outside the normal range or any other laboratory value outside the reference range that is of clinical relevance
- Inability to comply with dietary regimen of trial site
- Galactose or lactose intolerance, galactose or glucose malabsorption
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT02276365
Start Date
June 1 2009
Last Update
October 28 2014
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