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CompletedNCT00802087Updated Aug 29, 2016

Single Dose Pharmacokinetics of Egalet® Hydrocodone

A Phase 1 interventional study of hydrocodone and hydrocodone & acetaminophen combination in Pain, sponsored by Egalet Ltd. Completed at 1 site in Canada. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-08-29.

Sponsored by Egalet Ltd · Phase 1 and Interventional

Phase
Phase 1
Study type
Interventional
Enrollment
28
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

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.

Read the detailed description

Outcomes:

Pharmacokinetic parameters and bioequivalence testing.

02

Conditions studied

  • Pain

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Keywords

  • Hydrocodone
  • Pharmacokinetics
  • Safety & Tolerability
03

In context

Pain

2,450 studies on the registry are indexed under Pain; 945 are open to participants now.

This study's enrollment of 28 is below the median of 70 across 2,101 interventional studies indexed under Pain.

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Lead sponsor

Egalet Ltd is the lead sponsor of 20 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Phase 1
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
28 participants (actual)

Study arms

  • Experimental
    Egalet® hydrocodone treatment A

    Single Dose administration

    Drug: hydrocodone

  • Experimental
    Egalet® hydrocodone Treatment B

    Single Dose Administration

    Drug: hydrocodone

  • Experimental
    Egalet® hydrocodone Treatment C

    Single Dose Administration

    Drug: hydrocodone

  • Experimental
    Egalet® hydrocodone Treatment D

    Single Dose Administration

    Drug: hydrocodone

  • Active comparator
    Active Comparator

    Single Dose Administration

    Drug: hydrocodone & acetaminophen combination

Interventions

  • Drughydrocodone

    Extended Release tablet

  • Drughydrocodone & acetaminophen combination

    Immediate Release tablet, hydrocodone and acetaminophen combination product

06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

07

Study locations

1 site
  • Montreal, Quebec, Canada
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 29, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00802087
Lead sponsor
Egalet Ltd
Responsible party
Sponsor
First posted
Dec 4, 2008
Start date
Nov 2008
Primary completion
Dec 2008
Completion
Apr 2009
Last update
Aug 29, 2016

Study contacts

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

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2016. You cannot join it, but the record below documents what was studied.

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