Single Dose Pharmacokinetics of Egalet® Hydrocodone

August 26, 2016 updated by: Egalet Ltd

A Single-Centre, Single Dose, Randomized,Open Label, Exploratory, 5-way Crossover Study Evaluating the Pharmakokinetic Profiles of Various Egalet® Hydrocodone Formulations In Healthy Volunteers Under Fasting Conditions.

The purpose of the study is to evaluate the pharmacokinetic profile of different Egalet® hydrocodone formulations and compare to a marketed hydrocodone drug.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Outcomes:

Pharmacokinetic parameters and bioequivalence testing.

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Montreal, Quebec, Canada

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Non-smokers
  • ≥18 and ≤55 years of age
  • BMI ≥19 and ≤30.0

Exclusion Criteria:

  • Clinically significant abnormalities, physical or psychological illnesses or conditions contraindicating hydrocodone treatment
  • History of significant abuse, dependance or addiction of alcohol, drugs or hard drugs within one year prior to screening
  • Allergic to hydrocodone, hydromorphone, other opioids, or related drugs
  • Use of any drugs known to induce or inhibit hepatic drug metabolism within 30 days prior to study drug administration
  • Pregnant or breast-feeding

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Egalet® hydrocodone treatment A
Single Dose administration
Drug: hydrocodone
Extended Release tablet
Experimental: Egalet® hydrocodone Treatment B
Single Dose Administration
Drug: hydrocodone
Extended Release tablet
Experimental: Egalet® hydrocodone Treatment C
Single Dose Administration
Drug: hydrocodone
Extended Release tablet
Experimental: Egalet® hydrocodone Treatment D
Single Dose Administration
Drug: hydrocodone
Extended Release tablet
Active Comparator: Active Comparator
Single Dose Administration
Drug: hydrocodone & acetaminophen combination
Immediate Release tablet, hydrocodone and acetaminophen combination product

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To evaluate the Pharmacokinetics of Egalet® hydrocodone formulations. PK Parameters: AUC0-t, AUC0-inf, Cmax, Residual Area, Tmax, T½ el, Kel, MRT, proportion of AUC before Tmax, AUC0-12 and AUC0-24
Time Frame: Single-dose evaluation
Single-dose evaluation

Secondary Outcome Measures

Outcome Measure
Time Frame
To evaluate safety and tolerability of Egalet® hydrocodone formulations. Hematology, biochemistry, urinalysis, ECG, vital signs (including pulse oximetry), and adverse events monitoring.
Time Frame: Single-dose evaluation
Single-dose evaluation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Egalet Ltd

Investigators

  • Study Director: Christine Andersen, M.Sc.Pharm, Egalet A/S

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2008

Primary Completion (Actual)

December 1, 2008

Study Completion (Actual)

April 1, 2009

Study Registration Dates

First Submitted

December 2, 2008

First Submitted That Met QC Criteria

December 3, 2008

First Posted (Estimate)

December 4, 2008

Study Record Updates

Last Update Posted (Estimate)

August 29, 2016

Last Update Submitted That Met QC Criteria

August 26, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HC-EG-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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