Determination of the relative bioavailability of 2 different formulations of a 5 mg linagliptin (BI 1356)/45 mg pioglitazone fixed dose combination (FDC) tablet, formulation C5 and formulation C8, compared with the mono-components linagliptin and pioglitazone administered together
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
39
film coated tablet (5 mg/45 mg)
film coated tablet (5 mg/45 mg)
5 mg
AUC0-72 (area under the concentration-time curve of linagliptin in plasma over the time interval from 0 to 72 h)
Time frame: 1 hour prior drug administration and up to 120 h after drug administration
Cmax (maximum measured concentration of linagliptin in plasma)
Time frame: 1 hour prior drug administration and up to 120 h after drug administration
AUC0-infinity (area under the concentration-time curve of pioglitazone in plasma over the time interval from 0 extrapolated to infinity)
Time frame: 1 hour prior drug administration and up to 72 h after drug administration
Cmax (maximum measured concentration of pioglitazone in plasma)
Time frame: 1 hour prior drug administration and up to 72 h after drug administration
AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point)
Time frame: 1 hour prior drug administration and up to 120 h after drug administration
AUC0-infinity (area under the concentration-time curve of linagliptin in plasma over the time interval from 0 extrapolated to infinity)
Time frame: 1 hour prior drug administration and up to 120 h after drug administration
AUC0-72 (area under the concentration-time curve of pioglitazone in plasma over the time interval from 0 to 72 h)
Time frame: 1 hour prior drug administration and up to 72 after drug administration
Changes from baseline in vital signs (blood pressure (BP) and pulse rate (PR))
Time frame: 21 to 1 day prior start of treatment, at study visits 2 to 4 (prior to treatment administration and 24 h following treatment administration), and 7 days after last treatment administration
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45 mg
Occurrence of adverse events (AEs)
Time frame: until 7 days after last treatment administration
Assessment of tolerability by the investigator
Time frame: on day 6 of each treatment and 7 days after last treatment administration