Healthy
Conditions
Brief summary
Study to investigate the relative bioavailability of BI 10773 and of linagliptin after concomitant multiple oral administration of 50 mg BI 10773 tablets and 5 mg linagliptin in comparison to 50 mg BI 10773 and 5 mg linagliptin given alone.
Interventions
DRUGBI 10773
DRUGLinagliptin
Sponsors
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy male volunteers according to the following criteria: * Based upon a complete medical history and physical examination including vital signs (BP (blood pressure), PR (pulse rate)), 12-lead ECG (electrocardiogram) and clinical laboratory tests * Age 18 to 50 years (inclusive) * BMI 18.5 to 29.9 kg/m2 (inclusive) * Signed and dated written informed consent prior to admission to the study in accordance with GCP (Good Clinical Practice) and the local legislation.
Exclusion criteria
* 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 (\> 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 (\> 10 cigarettes or \> 3 cigars or \> 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) * Any laboratory value outside the reference range that is of clinical relevance * Inability to comply with dietary regimen of trial site
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AUCτ,ss (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ) | up to day 8 |
| Cmax,ss (maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ) | up to day 8 |
Secondary
| Measure | Time frame |
|---|---|
| Plasma DPP-4 (Dipeptidyl-peptidase 4) inhibition | 2 hours and 24 hours after last administration of study drug |
| Changes from baseline in physical examination | Baseline and within 5 days after last study drug administration |
| Changes from baseline in vital signs (blood pressure, pulse rate) | Baseline, day 1 and within 5 days after last study drug administration |
| tmax,ss (time from last dosing to the maximum measured concentration of each analyte in plasma at steady state) | up to day 8 |
| Changes from baseline clinical laboratory tests | Baseline, day 1 and within 5 days after last study drug administration |
| Incidence of adverse events | Up to 56 days |
| Assessment of tolerability by investigator on a 4-point scale | Within 5 days after last study drug administration |
| Changes from baseline in 12-lead ECG (electrocardiogram) | Baseline and within 5 days after last study drug administration |
| Urine glucose excretion (UGE) | Pre-dose and 0-2, 2-4, 4-8, 8-12, 12-24 hours after the last dosing of each visit |
Outcome results
None listed