Pharmacokinetics of Kava and Kratom Alone and in Combination
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-55
SponsorBotanic Tonics, LLC
About this trial
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.
Eligibility criteria
Qualifiers
Adults who are between 21 - 55 years of age (inclusive) at the time of signing the informed consent.
In otherwise good general health, as deemed by the investigator (based on review of medical history, vital signs, laboratory safety tests, and physical examination performed at screening and/or before the first dose of study product).
Are able to consume the study product completely within the specified timeframe.
Not currently using, defined as ≤ 3 uses in the past 3 months prior to Visit 2, any nicotine-containing products (patches, gums, vapes, etc.), kava products, and/or kratom products, and willing to abstain starting 14 days prior to Visit 2 and throughout the study.
Disqualifiers
Individuals who are lactating, planning to become pregnant during the study, or pregnant as confirmed by a positive pregnancy test during study visits.
Have a known sensitivity, intolerability, or allergy to any of the study products, their excipients, or rescue medication.
Demonstrates a positive urine drug screen test for compounds listed in Table 8 4 at the Screening Visit or Visit 2, a positive urine cotinine test at the Screening Visit or Visit 2, or a positive breath alcohol test at Screening Visit or Visit 2.
Have abnormal respiratory rate (RR) or SpO2 measurements at Screening or Baseline at the discretion of the investigator.
Trial design
Treatments tested in this trial
- Kava and Kratom Herbal Supplement
- Kava Herbal Supplement
- Kratom Herbal Supplement
Treatment groups
18 Participants
are divided into 3 treatment groupsSponsors and collaborators
Botanic Tonics, LLC
Lead sponsor
Nutrasource Pharmaceutical and Nutraceutical Services, Inc.
Collaborator
Source ClinicalTrials.gov