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Omnitram Pharmacokinetic Study In Healthy Volunteers

NCT02205554 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2014-10-15

No results posted yet for this 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.

Conditions

Interventions

DRUG

Omnitram

Nine 20 mg doses administered every 6 hours

DRUG

Tramadol

Nine 50 mg doses administered every 6 hours.

DRUG

Placebo

Nine doses administered every 6 hours.

Sponsors & Collaborators

  • National Institute on Drug Abuse (NIDA)

    collaborator NIH

  • Syntrix Biosystems, Inc.

    lead INDUSTRY

Principal Investigators

  • Shawn Searle, MD · PRA/CRI Lifetree Research Center

  • Stuart Kahn, MD · Syntrix Biosystems, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
21 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-08-31
Primary Completion
2014-10-31
Completion
2014-10-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02205554 on ClinicalTrials.gov