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NCT04603391 · ClinicalTrials.gov registry record · Phase 4
Cannabidiol and CES1 Interactions in Healthy Subjects
A Phase 4 study, sponsored by University of Florida.
- Completed
- Registry status
- Phase 4
- Development phase
- 14
- Enrollment target
NCT04603391: Completed Phase 4 study, sponsored by University of Florida.
NCT04603391 is a Phase 4 study that has completed, run by University of Florida. The registered enrollment target is 14 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04603391, a Phase 4 study, has completed, sponsored by University of Florida.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 14 participants
- Enrollment target
Study 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
Primary Outcome
Plasma methylphenidate (MPH) concentrations for both arms were determined by using a liquid-liquid extraction method and LC-MS/MS analysis. Peak concentration (Cmax) was reported as observed for each subject. The geometric mean ratios (GMR) of the Cmax for MPH were compared between the two exposure conditions, i.e., MPH with CBD versus MPH with placebo. In brief, if the 90% confidence interval (CI) of GMR for Cmax between the CBD group and placebo group extend beyond the FDA's established bioequ
Interventions
- DRUG dl-Methylphenidate plus Cannabidiol
- DRUG dl-Methylphenidate plus Cannabidiol Placebo solution
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2021-02-25 |
| Est. Completion | 2021-12-31 |
| Phase | Phase 4 |
What the finished NCT04603391 record still lists
NCT04603391 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 2 interventions - of which dl-Methylphenidate plus Cannabidiol is the first listed.
NCT04603391 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04603391 about?
NCT04603391 is a clinical study titled "Cannabidiol and CES1 Interactions in Healthy Subjects". 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
What is the current status of trial NCT04603391?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 14 participants. The study started on 2021-02-25. Estimated completion is 2021-12-31.
What interventions are being tested in trial NCT04603391?
The interventions under investigation include: dl-Methylphenidate plus Cannabidiol (DRUG), dl-Methylphenidate plus Cannabidiol Placebo solution (DRUG).
Who is sponsoring clinical trial NCT04603391?
This trial is sponsored by University of Florida, which has 1,106 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04603391's enrollment target sits among peer trials
14 1901st of 2000 higher than 91 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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