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NCT03420469 · ClinicalTrials.gov registry record · Early Phase 1
Bupropion Stereoselective Disposition and CYP2D6-mediated Drug Interactions in Healthy Volunteers
A Early Phase 1 study, sponsored by Indiana University.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 28
- Enrollment target
NCT03420469: Completed Early Phase 1 study, sponsored by Indiana University.
NCT03420469 is a Early Phase 1 study that has completed, run by Indiana University. The registered enrollment target is 28 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (47% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03420469, a Early Phase 1 study, has completed, sponsored by Indiana University.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 28 participants
- Enrollment target
Study Summary
Primary objectives: 1. To comprehensively characterize steady state stereoselective pharmacokinetics of bupropion and its primary and secondary metabolites in healthy volunteers 2. To prospectively determine the time course (onset), extent and offset of CYP2D6 inhibition in relation to the pharmacokinetic profiles of bupropion and metabolites.
Primary Outcome
Area under the plasma concentration versus time curves (AUC0-inf) of bupropion and its metabolites as well as CYP2D6 activity measured by dextromethorphan to dextrorphan
Interventions
- DRUG Bupropion
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2018-06-05 |
| Est. Completion | 2019-05-01 |
| Phase | Early Phase 1 |
What the finished NCT03420469 record still lists
NCT03420469 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (47% lower).
The record links to 0 conditions, and to 1 intervention - of which Bupropion is the first listed.
NCT03420469 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03420469 about?
NCT03420469 is a clinical study titled "Bupropion Stereoselective Disposition and CYP2D6-mediated Drug Interactions in Healthy Volunteers". Primary objectives: 1. To comprehensively characterize steady state stereoselective pharmacokinetics of bupropion and its primary and secondary metabolites in healthy volunteers 2. To prospectively determine the time course (onset), extent and offset of CYP2D6 inhibition in relation to the pharmaco...
What is the current status of trial NCT03420469?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 28 participants. The study started on 2018-06-05. Estimated completion is 2019-05-01.
What interventions are being tested in trial NCT03420469?
The interventions under investigation include: Bupropion (DRUG).
Who is sponsoring clinical trial NCT03420469?
This trial is sponsored by Indiana University, which has 890 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03420469's enrollment target sits among peer trials
28 938th of 2000 higher than 1,038 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 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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