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A Phased Clinical Trial of Dietary Supplemental Kava: Kava Pharmacokinetics

NCT03843502 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2024-06-12

Study results available
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Summary

Kava is a dietary supplement on the US market and is experiencing a resurgence of its use. Its pharmacokinetic information, however, is lacking which is important for its future effective usage as a dietary supplement or potentially as a botanical therapeutics. This phased trial, based on the recommendation from NIH, is to collect pharmacokinetic data of kava in healthy subjects.

Conditions

  • Pharmacokinetics

Interventions

DRUG

Kava Dietary Supplement

Participants will be given three 75mg kava capsules.

Sponsors & Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)

    collaborator NIH

  • Thorne HealthTech, Inc

    collaborator INDUSTRY

  • University of Florida

    lead OTHER

Principal Investigators

  • Carol Mathews, MD · University of Florida

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2020-02-26
Primary Completion
2021-04-21
Completion
2021-07-13
FDA Drug
Yes

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 NCT03843502 on ClinicalTrials.gov