Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Kowa Research Institute, Inc.
Age
18–any
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
Subject is an adult male or female subject aged 18 years or older. Females of childbearing potential must have a negative pregnancy test before beginning the study.
Subject has no clinically significant medical conditions (other than renal impairment and associated diseases, such as hypertension, diabetes, and dyslipidemia, for subjects in Group A) as determined by medical history, physical examination, 12-lead ECG, clinical laboratory results (hematology, serum chemistry, and urinalysis \[if able to pass urine\]), and serology results (hepatitis B surface antigen, hepatitis C virus antibody, and human immunodeficiency virus types 1 and 2 antibody). Subjects with positive results for hepatitis C virus but who have normal liver enzymes will not be excluded. Any subjects who have impaired hepatic function that will potentially affect drug metabolism should be excluded.
Subject provides written informed consent before any study-specific evaluation is performed.
Subject is able and willing to comply with the protocol and study procedures.
You may not be if
Subject is on maintenance hemodialysis.
Subject has a BMI of \>37 kg/m2.
Clareo Health | Safety, Tolerability, and Pharmacokinetic of Single Dose of Pitavastatin 4 mg in Severe Renal Patients Versus Healthy Adult Volunteers
