Relative Bioavailability of BI 10773 and Linagliptin in Healthy Male Volunteers

Study Overview
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Brief Summary
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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.

Official Title
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Relative Bioavailability of Multiple Doses BI 10773 50 mg and Linagliptin 5 mg After Concomitant Administration Compared to Multiple Doses of BI 10773 50 mg and Linagliptin 5mg Administered Alone to Healthy Male Volunteers (an Open-label, Randomised, Crossover, Clinical Phase I Study)

Conditions
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Healthy

Intervention / Treatment
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* Drug: BI 10773
* Drug: Linagliptin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sequence ABC<br>Treatment A: BI 10773 once daily from day 1 to 5 Treatment B: BI10773 and linagliptin once daily from day 1 to 7 Treatment C: Linagliptin once daily from day 1 to 7 | Drug: BI 10773<br> <br> Drug: Linagliptin<br> <br> |
| Experimental: Sequence CAB<br>Treatment C: Linagliptin once daily from day 1 to 7 Treatment A: BI 10773 once daily from day 1 to 5 Treatment B: BI10773 and linagliptin once daily from day 1 to 7 | Drug: BI 10773<br> <br> Drug: Linagliptin<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| tmax,ss (time from last dosing to the maximum measured concentration of each analyte in plasma at steady state) |  | up to day 8 | 
| 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 | 
| 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 | 
| Changes from baseline in 12-lead ECG (electrocardiogram) |  | Baseline and within 5 days after last study drug administration | 
| 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 |