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Cannabidiol and CES1 Interactions in Healthy Subjects

NCT04603391 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2024-07-18

Study results available
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Summary

The proposed study will assess the drug interaction potential between oral cannabidiol (Epidiolex®) and the carboxylesterase 1 (CES1) substrate methylphenidate (Ritalin®) in 12 healthy research subjects

Conditions

  • Drug Interaction

Interventions

DRUG

dl-Methylphenidate plus Cannabidiol

Subjects will be administered one 10 mg tablet of dl-methylphenidate (Ritalin®) plus 7.5 mL Epidiolex® solution

DRUG

dl-Methylphenidate plus Cannabidiol Placebo solution

Subjects will be administered one 10 mg tablet of dl-methylphenidate (Ritalin®) plus 7.5 mL of Epidiolex® placebo solution

Sponsors & Collaborators

  • Consortium for Medical Marijuana Clinical Outcomes Research

    collaborator OTHER

  • University of Florida

    lead OTHER

Principal Investigators

  • John Markowitz, Pharm.D · University of Florida

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2021-02-25
Primary Completion
2021-12-31
Completion
2021-12-31
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 NCT04603391 on ClinicalTrials.gov