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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.

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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

FieldValue
Enrollment Target 43 participants
Start Date 2014-08
Est. Completion 2014-10
Phase Phase 1
Syntrix Biosystems

9 total trials

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.

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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Source: ClinicalTrials.gov NCT02205554, the US trial registry maintained by the National Library of Medicine. NCT02205554 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.