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Developmental Regulation of Proteins Responsible for Transforming Drugs in the Body

NCT00117715 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 121

Last updated 2017-09-12

Study results available
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Summary

This is a drug metabolism study in one-year old children involving caffeine and dextromethorphan.

Conditions

  • Healthy

Interventions

PROCEDURE

Genotyping and Phenotyping using dextromethorphan and caffeine as probes

Single doses of dextromethorphan (0.3 mg/kg)and caffeine (3.0 mg/kg) are administered and urine is collected overnight for measurement of drug and metabolites to determine drug biotransformation activity.

Sponsors & Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • Children's Mercy Hospital Kansas City

    lead OTHER

Principal Investigators

  • J. Steven Leeder, Pharm. D, Ph.D. · Children's Mercy Hospital Kansas City

Eligibility

Min Age
12 Months
Max Age
5 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2000-10-31
Primary Completion
2010-01-31
Completion
2010-01-31

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 NCT00117715 on ClinicalTrials.gov