The goal of this study is to assess dabigatran pharmacokinetics in NVAF subjects with severe renal impairment defined as creatinine clearance between 15 and 30 mL/min calculated by Cockcroft-Gault formula. The dabigatran etexilate dose of 75 mg BID was approved by the FDA for NVAF patients with severe renal impairment (CrCl 15-30 mL/min) , based on pharmacokinetic modeling and simulation.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
63
75mg BID by oral
Pre-dose Concentration of the Analyte in Plasma at Steady State Immediately Before Administration of the Next Dose
Pre-dose concentration of the analyte in plasma at steady state immediately before administration of the next dose (Cpre,ss) taken at approximately 12 hours after the last dose (trough).
Time frame: Immediately before the last drug administration, on day 8
Concentration of Analyte in Plasma at Steady State at 2 Hours After Administration of the Last Dose
Concentration of analyte in plasma at steady state at 2 hours after administration of the last dose (C2,ss)
Time frame: 2 hours after the last drug administration, on day 8
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1160.173.002 Boehringer Ingelheim Investigational Site
Hot Springs, Arkansas, United States
1160.173.023 Boehringer Ingelheim Investigational Site
Fremont, California, United States
1160.173.032 Boehringer Ingelheim Investigational Site
Moreno Valley, California, United States
1160.173.034 Boehringer Ingelheim Investigational Site
Oceanside, California, United States
1160.173.025 Boehringer Ingelheim Investigational Site
Salinas, California, United States
1160.173.033 Boehringer Ingelheim Investigational Site
San Pedro, California, United States
1160.173.024 Boehringer Ingelheim Investigational Site
Wilmington, Delaware, United States
1160.173.010 Boehringer Ingelheim Investigational Site
Washington D.C., District of Columbia, United States
1160.173.020 Boehringer Ingelheim Investigational Site
Jacksonville, Florida, United States
1160.173.036 Boehringer Ingelheim Investigational Site
Jacksonville, Florida, United States
...and 16 more locations