Evaluating the Pharmacokinetics of Oregano and Potential Oregano-drug Interactions Using a Drug Cocktail Approach

Part of paid clinical trials in Spokane, Washington.

Sponsor
Washington State University
Study ID
NCT06693960
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

  • Interaction

Eligibility Criteria

Sex
ALL
Age
18 Years - 64 Years
Healthy Volunteers
Accepted

Interventions

  • Oregano — DIETARY_SUPPLEMENT
    Oil of oregano administered as a softgel (180 mg).
  • Drug cocktail — DRUG
    Oral drug cocktail consisting of caffeine (100 mg), dextromethorphan (30 mg), losartan (25 mg), midazolam syrup (2 mg), and omeprazole (20 mg).

Study Details

The purpose of this clinical trial is to determine how the supplement oregano affects how the body metabolizes pharmaceutical drugs.

Key Dates

Start date
Sep 26, 2024
Status verified
Jun 2026
Primary completion
Dec 15, 2026
Completion
Jan 31, 2027

Study Design

Enrollment
16 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Arm 1: oregano alone
    6 participants will be administered 180 mg of a well-characterized oregano product. Blood will be drawn via an indwelling venous catheter immediately before and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours after administration of oregano. Urine will be collected in multiple jugs for 24 hours.
  • Experimental: Arm 2: drug cocktail alone
    16 participants, which may or may not include any number of the original 6 from Arm 1, will be administered an oral drug cocktail consisting of caffeine (100 mg), dextromethorphan (30 mg), losartan (25 mg), midazolam syrup (2 mg), and omeprazole (20 mg). Blood and urine will be collected in the same manner described in Arm 1.
  • Experimental: Arm 3: acute oregano + cocktail
    The same 16 participants will be administered the oregano product and the drug cocktail. Blood and urine will be collected in the same manner described in Arm 1.
  • Experimental: Arm 4: chronic oregano + cocktail
    The same 16 participants will self-administer the oregano product at home for 5 consecutive days. On day 6, participants will return to the study setting, where the procedure described in Arm 3 will be repeated.

Primary Outcome Measure

Midazolam Area under the plasma concentration vs. time curve (AUC) ratio [ Time Frame: 0-24 hours ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Washington State University College of Pharmacy and Pharmaceutical SciencesSpokaneWashington99202
Mary F Paine, RPh, PhD
[email protected]
509-358-7759
Mary F Paine, RPh, PhD (PRINCIPAL_INVESTIGATOR)
Matthew Layton, MD, PhD (SUB_INVESTIGATOR)
John White, PharmD, PA-C (SUB_INVESTIGATOR)

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By research site
Washington State University College of Pharmacy and Pharmaceutical Sciences· Spokane, WA

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