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NCT01367535 · ClinicalTrials.gov registry record · Phase 1
Effects of MNTX on CYP450 2D6 in Metabolizers of Dextromethorphan
A Phase 1 study, sponsored by Bausch Health Americas.
- Completed
- Registry status
- Phase 1
- Development phase
- 54
- Enrollment target
NCT01367535 is a Phase 1 study that has completed, run by Bausch Health Americas. The registered enrollment target is 54 participants.
The verdict
NCT01367535, a Phase 1 study, has completed, sponsored by Bausch Health Americas.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 54 participants
- Enrollment target
Study Summary
This study is a single-center, randomized, open-label, active and placebo-controlled, parallel-group, conducted in healthy male volunteers who have been shown to be extensive metabolizers of dextromethorphan.
Interventions
- DRUG SC Placebo
- DRUG IV Methylnaltrexone (MNTX)
- DRUG SC Methylnaltrexone (MNTX)
- DRUG Oral Paroxetine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 54 participants |
| Start Date | 2006-03 |
| Est. Completion | 2006-08 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01367535
The ClinicalTrials.gov registry entry for NCT01367535 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 54 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bausch Health Americas, which has 168 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which SC Placebo is the first listed.
NCT01367535 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01367535 about?
NCT01367535 is a clinical study titled "Effects of MNTX on CYP450 2D6 in Metabolizers of Dextromethorphan". This study is a single-center, randomized, open-label, active and placebo-controlled, parallel-group, conducted in healthy male volunteers who have been shown to be extensive metabolizers of dextromethorphan.
What is the current status of trial NCT01367535?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 54 participants. The study started on 2006-03. Estimated completion is 2006-08.
What interventions are being tested in trial NCT01367535?
The interventions under investigation include: SC Placebo (DRUG), IV Methylnaltrexone (MNTX) (DRUG), SC Methylnaltrexone (MNTX) (DRUG), Oral Paroxetine (DRUG).
Who is sponsoring clinical trial NCT01367535?
This trial is sponsored by Bausch Health Americas, which has 168 total clinical trials registered on ClinicalTrials.gov.
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