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Safety and Pharmacokinetics of an Extract of Naringenin

NCT03582553 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2020-01-18

Study results available
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Summary

This study evaluates the safety of administering single ascending doses (150, 300, 600, and 900 mg) of a citrus extract of the flavonoid narigenin, and assesses the blood concentrations of naringenin following oral administration of the extract.

Conditions

  • Safety Issues
  • Pharmacokinetics

Interventions

DIETARY_SUPPLEMENT

Naringenin

An extract of Citrus Sinensis containing naringenin and its precursor naringin

OTHER

Placebo

Cellulose

Sponsors & Collaborators

  • Louisiana Clinical and Translational Science Center

    collaborator OTHER

  • Pennington Biomedical Research Center

    lead OTHER

Principal Investigators

  • Candida Rebello · Pennington Biomedical Research Center

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-05-25
Primary Completion
2018-09-28
Completion
2018-09-28

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 NCT03582553 on ClinicalTrials.gov