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NCT02205554 · ClinicalTrials.gov registry record · Phase 1
Omnitram Pharmacokinetic Study In Healthy Volunteers
A Phase 1 study, sponsored by Syntrix Biosystems.
- Completed
- Registry status
- Phase 1
- Development phase
- 43
- Enrollment target
NCT02205554: Completed Phase 1 study, sponsored by Syntrix Biosystems.
NCT02205554 is a Phase 1 study that has completed, run by Syntrix Biosystems. The registered enrollment target is 43 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (28% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02205554, a Phase 1 study, has completed, sponsored by Syntrix Biosystems.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 43 participants
- Enrollment target
Study Summary
The purpose of this study is to compare the safety, pharmacokinetic properties (the absorption, distribution and excretion), and analgesic activity of Omnitram (10 mg tablets), Tramadol (Ultram, 50 mg tablet) following oral administration of 9 doses healthy subjects.
Interventions
- DRUG Placebo
- DRUG Tramadol
- DRUG Omnitram
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 43 participants |
| Start Date | 2014-08 |
| Est. Completion | 2014-10 |
| Phase | Phase 1 |
What the finished NCT02205554 record still lists
NCT02205554 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 43 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (28% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT02205554 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02205554 about?
NCT02205554 is a clinical study titled "Omnitram Pharmacokinetic Study In Healthy Volunteers". The purpose of this study is to compare the safety, pharmacokinetic properties (the absorption, distribution and excretion), and analgesic activity of Omnitram (10 mg tablets), Tramadol (Ultram, 50 mg tablet) following oral administration of 9 doses healthy subjects.
What is the current status of trial NCT02205554?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 43 participants. The study started on 2014-08. Estimated completion is 2014-10.
What interventions are being tested in trial NCT02205554?
The interventions under investigation include: Placebo (DRUG), Tramadol (DRUG), Omnitram (DRUG).
Who is sponsoring clinical trial NCT02205554?
This trial is sponsored by Syntrix Biosystems, which has 9 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02205554's enrollment target sits among peer trials
43 1100th of 2000 higher than 896 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other 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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