Effects of Varying Degrees of Renal Impairment on the Pharmacokinetics of Duloxetine Analysis of a Single-Dose Phase I Study and Pooled Steady-State Data from Phase II/III Trials

• Published in: Clinical pharmacokinetics Vol. 49; no. 5; pp. 311 - 321
• Main Authors: Lobo, Evelyn D., Heathman, Michael, Kuan, Han-Yi, Reddy, Shobha, O’Brien, Lisa, Gonzales, Celedon, Skinner, Michael, Knadler, Mary Pat
• Format: Journal Article
• Language: English
• Published: Cham Springer International Publishing 01.05.2010; Adis International; Wolters Kluwer Health, Inc; Springer Nature B.V
• Subjects: Adult; Biological and medical sciences; Dose-Response Relationship, Drug; Double-Blind Method; Drug Administration Schedule; Drug therapy; Duloxetine Hydrochloride; Female; General pharmacology; Humans; Internal Medicine; Kidney Failure, Chronic - blood; Kidney Failure, Chronic - drug therapy; Kidney Failure, Chronic - pathology; Major depressive disorder; Male; Medical sciences; Medicine; Medicine & Public Health; Metabolic Clearance Rate - drug effects; Metabolic Clearance Rate - physiology; Middle Aged; Nephrology. Urinary tract diseases; Nephropathies. Renovascular diseases. Renal failure; Original Research Article; Pharmacokinetics; Pharmacokinetics. Pharmacogenetics. Drug-receptor interactions; Pharmacology. Drug treatments; Pharmacology/Toxicology; Pharmacotherapy; Renal failure; Thiophenes - administration & dosage; Thiophenes - pharmacokinetics; Thiophenes - therapeutic use; United States; Normal Renal Function; Renal Impairment; Stress Urinary Incontinence; Duloxetine; Major Depressive Disorder; Kidney disease; Phase III trial; Human; Urinary system disease; Serotonin; Psychotropic; Single dose; Catecholamine; Reuptake inhibitor; Chemotherapy; Nephropathy; Treatment; Phase II trial; Renal failure; Neurotransmitter; Phase I trial; Antidepressant agent; Norepinephrine; Pharmacokinetics

Background Duloxetine is indicated for patients with a variety of conditions, and some of these patients may have mild to moderate degrees of renal impairment. Renal impairment may affect the pharmacokinetics of a drug by causing changes in absorption, distribution, protein binding, renal excretion...