drugset / Trial / NCT00785551

Comparative Study of Quinine Sulfate in Healthy Patients and in Patients With Renal Impairment

NCT00785551

Phase 1 Terminated 5 enrolled Mutual Pharmaceutical Company, Inc.
Non-randomizedParallel-groupOpen-labelBasic science

Summary

The effects of mild or moderate renal impairment (creatinine clearance 30 to 50 ml/min or \>50 to 80 ml/min, respectively) on the pharmacokinetic profile of quinine and its active metabolite, 3'-hydroxyquinine, will be investigated. Safety and tolerability in healthy subjects versus those with mild to moderate renal impairment will be compared, as well.

Timeline

Start
2007-11
Primary completion
2011-01
Completion
2011-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Quinine Small molecule 648 mg Oral