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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
16
AUCτ,ss (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ)
Time frame: up to day 8
Cmax,ss (maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ)
Time frame: up to day 8
tmax,ss (time from last dosing to the maximum measured concentration of each analyte in plasma at steady state)
Time frame: up to day 8
Urine glucose excretion (UGE)
Time frame: 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
Time frame: 2 hours and 24 hours after last administration of study drug
Changes from baseline in physical examination
Time frame: Baseline and within 5 days after last study drug administration
Changes from baseline in vital signs (blood pressure, pulse rate)
Time frame: Baseline, day 1 and within 5 days after last study drug administration
Changes from baseline in 12-lead ECG (electrocardiogram)
Time frame: Baseline and within 5 days after last study drug administration
Changes from baseline clinical laboratory tests
Time frame: Baseline, day 1 and within 5 days after last study drug administration
Incidence of adverse events
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Time frame: Up to 56 days
Assessment of tolerability by investigator on a 4-point scale
Time frame: Within 5 days after last study drug administration