Severe Renal Impairment Clinical Trial
Official title:
A Study to Compare the Safety, Tolerability, and Pharmacokinetic Profile of a Single Oral Dose of Pitavastatin 4 mg in Adult Volunteers With Severe Renal Impairment Who Are Not Being Treated With Hemodialysis Versus Healthy Adult Volunteers
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.
n/a
Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label
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