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

NCT00785551 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2012-08-01

No results posted yet for this study

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.

Conditions

  • Healthy
  • Renal Impairment

Interventions

DRUG

quinine sulfate

2 x 324mg given in one dose to healthy subjects

DRUG

quinine sulfate

2 x 324mg given as one dose to subjects with mild renal impairment

DRUG

quinine sulfate

2 x 324mg given as one dose to subjects with moderate renal impairment

Sponsors & Collaborators

  • Mutual Pharmaceutical Company, Inc.

    lead INDUSTRY

Principal Investigators

  • Matthew Davis, M.D. · Mutual Pharmaceutical

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-11-30
Primary Completion
2011-01-31
Completion
2011-01-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00785551 on ClinicalTrials.gov