Single Dose Pharmacokinetics of Egalet® Hydrocodone
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.
1 other identifier
interventional
28
1 country
1
Brief Summary
The purpose of the study is to evaluate the pharmacokinetic profile of different Egalet® hydrocodone formulations and compare to a marketed hydrocodone drug.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 pain
Started Nov 2008
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2008
CompletedFirst Submitted
Initial submission to the registry
December 2, 2008
CompletedFirst Posted
Study publicly available on registry
December 4, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2009
CompletedAugust 29, 2016
August 1, 2016
1 month
December 2, 2008
August 26, 2016
Conditions
Keywords
Outcome Measures
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
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.
Single-dose evaluation
Study Arms (5)
Egalet® hydrocodone treatment A
EXPERIMENTALSingle Dose administration
Egalet® hydrocodone Treatment B
EXPERIMENTALSingle Dose Administration
Egalet® hydrocodone Treatment C
EXPERIMENTALSingle Dose Administration
Egalet® hydrocodone Treatment D
EXPERIMENTALSingle Dose Administration
Active Comparator
ACTIVE COMPARATORSingle Dose Administration
Interventions
Extended Release tablet
Immediate Release tablet, hydrocodone and acetaminophen combination product
Eligibility Criteria
You may qualify if:
- Non-smokers
- ≥18 and ≤55 years of age
- BMI ≥19 and ≤30.0
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Egalet Ltdlead
Study Sites (1)
Unknown Facility
Montreal, Quebec, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Christine Andersen, M.Sc.Pharm
Egalet A/S
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 2, 2008
First Posted
December 4, 2008
Study Start
November 1, 2008
Primary Completion
December 1, 2008
Study Completion
April 1, 2009
Last Updated
August 29, 2016
Record last verified: 2016-08