This is a Phase 4, multicenter, open label, 1 period study. A total of 16 subjects are planned (8 subjects in Group A and 8 subjects in Group B): The 2 groups will be comparable in terms of age, gender, and body mass index (BMI); the ranges for comparison will be obtained from the pooled demographic data of the renally impaired subjects. The mean age of Group B will be within 5 years of the mean age of Group A, the mean BMI of Group B will be within 18% of the mean BMI of Group A, and the ratio of men to women in Group B will be the same as in Group A.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Masking
NONE
Enrollment
16
Pitavastatin 4mg single dose
Unnamed facility
Minneapolis, Minnesota, United States
Area Under the Curve From 0 to Tau (AUC 0-t (ng*h/mL))
Area under the curve from start to elimination for Pitavastatin.
Time frame: 48 hours
Number of Participants With Treatment Emergent Adverse Events
Time frame: 3 Days
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