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Completed

NCT Number: NCT00802087

Single Dose Pharmacokinetics of Egalet® Hydrocodone

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

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Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Montreal, Quebec, Canada

About this study

Outcomes:

Pharmacokinetic parameters and bioequivalence testing.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hydrocodone

Drug

Extended Release tablet

hydrocodone & acetaminophen combination

Drug

Immediate Release tablet, hydrocodone and acetaminophen combination product

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

Sponsors and collaborators

Lead sponsor

Egalet Ltd

Industry

Registry information

Official study 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.

Important dates

Study start
2008
Primary completion
2008
Study completion
2009
First posted
Dec 4, 2008
Registry last updated
Aug 29, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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