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Omnitram Pharmacokinetic and Analgesic Study Following CY2D6 Inhibition With Paroxetine In Healthy Volunteers

NCT03312777 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2017-12-28

No results posted yet for this study

Summary

This study evaluates the analgesic effect of Omnitram and tramadol during concurrent administration of paroxetine. Paroxetine administration is expected to diminish the analgesic effect of tramadol, but not Omnitram. Each participant will receive paroxetine before and during treatment with Omnitram, tramadol, and placebo.

Conditions

Interventions

DRUG

Omnitram

Omnitram tablets overencapsulated

DRUG

Tramadol

Tramadol tablet overencapsulated

DRUG

Placebo

Microcrystalline powder overencapsulated

Sponsors & Collaborators

  • PRA Health Sciences

    collaborator INDUSTRY

  • DF/Net Rearch

    collaborator UNKNOWN

  • ITT Research Institute

    collaborator UNKNOWN

  • Syntrix Biosystems, Inc.

    lead INDUSTRY

Principal Investigators

  • Shawn L Searle, MD · PRA Health Sciences

  • Stuart Kahn, MD · Syntrix Biosystems

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-10-31
Primary Completion
2017-12-15
Completion
2017-12-22
FDA Drug
Yes

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 NCT03312777 on ClinicalTrials.gov