Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Wockhardt
With
Clinartis
Age
18–80
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
1. Body mass index (BMI) 18.0 and 40.0 (kg/m2) and body weight of at least 50 kg.
Patients with renal impairment:
2. Have a diagnosis of renal impairment that has been stable, without any change in overall disease status in the last 1 month
Healthy Subjects:
3. Have normal renal function with creatinine clearance more than 90 mL/min and no evidence of any disease or condition that may affect pharmacokinetics of FEP ZID.
4. A resting blood pressure 90-145 (systolic) / 60-95 (diastolic) mmHg for healthy volunteers and 90-155 (systolic) / 50-100 (diastolic) mmHg for patients with renal impairment.
You may not be if
1. History or presence of significant hematologic, pulmonary, cardiovascular, gastrointestinal, neurological, rheumatologic, hepatic, urologic, immunologic, infectious, skin and subcutaneous tissue, psychiatric or mood disorders (including any past suicide attempt), or uncontrolled metabolic or endocrine disorders (including diabetes, hypercholesterolemia, or dyslipidemia) that in the opinion of the Investigator would confound subject's participation and follow-up in the clinical trial.
2. Evidence of hepatorenal syndrome or acute glomerulonephritis
