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Single Dose Pharmacokinetics of Egalet® Hydrocodone

NCT00802087 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2016-08-29

No results posted yet for this study

Summary

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

Conditions

Interventions

DRUG

hydrocodone

Extended Release tablet

DRUG

hydrocodone & acetaminophen combination

Immediate Release tablet, hydrocodone and acetaminophen combination product

Sponsors & Collaborators

  • Egalet Ltd

    lead INDUSTRY

Principal Investigators

  • Christine Andersen, M.Sc.Pharm · Egalet A/S

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2008-11-30
Primary Completion
2008-12-31
Completion
2009-04-30

Countries

  • Canada

Study Locations

More Related Trials

Entities

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 NCT00802087 on ClinicalTrials.gov