Single Dose Pharmacokinetics of Egalet® Hydrocodone

Pain Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00802087
• Other study ID #: HC-EG-001
• Status: Completed
• Phase: Phase 1
• First received: December 2, 2008
• Last updated: August 26, 2016
• Start date: November 2008
• Est. completion date: April 2009

Study information

• Verified date: August 2016
• Source: Egalet Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

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

Description:

Outcomes:

Pharmacokinetic parameters and bioequivalence testing.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: April 2009
• Est. primary completion date: December 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• hydrocodone
Extended Release tablet
• hydrocodone & acetaminophen combination
Immediate Release tablet, hydrocodone and acetaminophen combination product

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Egalet Ltd

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	Yes