This study has been designed to confirm, in healthy subjects, the lack of a clinically important pharmacokinetic interaction between Dimebon, at the proposed maximum commercial dose of 20 mg TID (administered every 8 hours), and digoxin (Lanoxin®) 0.125 mg QD, a sensitive P-gp substrate recommended by FDA.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
12
Pfizer Investigational Site
New Haven, Connecticut, United States
AUC24 and Cmin of digoxin on Day 14
Time frame: Day 14
Cmax, Tmax, Ae, and renal clearance of digoxin on Day 14
Time frame: Day 14
Adverse event monitoring through Day 14 including physical/neurological examination findings
Time frame: Day 14
Clinical safety assessments through Day 14 including chemistry, hematology, and vital signs
Time frame: Day 14
12-lead ECGs through Day 14
Time frame: Day 14
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