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Pharmacokinetics of Kava and Kratom Alone and in Combination

NCT07583407 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2026-05-13

No results posted yet for this study

Summary

This study is being conducted to evaluate how different formulations of the Feel Free® Tonic containing Kava, Kratom, or a combination of both are processed in the body in healthy adults. The goal is to compare the pharmacokinetic profiles and safety of the combined herbal formulation with Kava alone and Kratom alone to better understand how these ingredients behave when taken individually versus together.

Conditions

  • Herb-Herb Interaction
  • Pharmacokinetics

Interventions

DIETARY_SUPPLEMENT

Kava and Kratom Herbal Supplement

Half- Strength Feel Free Classic Tonic (TP1)

DIETARY_SUPPLEMENT

Kava Herbal Supplement

Kava Only Variant - Feel Free Tonic (TP2)

DIETARY_SUPPLEMENT

Kratom Herbal Supplement

Kratom Only Variant - Feel Free Tonic (TP3)

Sponsors & Collaborators

  • Nutrasource Pharmaceutical and Nutraceutical Services, Inc.

    collaborator NETWORK

  • Botanic Tonics, LLC

    lead INDUSTRY

Principal Investigators

  • Ramsey Atallah · Botanic Tonics

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-05-04
Primary Completion
2026-09-04
Completion
2026-09-04

Countries

  • Canada

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 NCT07583407 on ClinicalTrials.gov