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Trial record 11 of 145 for:    Hydrocodone

Single Dose Pharmacokinetics of Egalet® Hydrocodone

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ClinicalTrials.gov Identifier: NCT00802087
Recruitment Status : Completed
First Posted : December 4, 2008
Last Update Posted : August 29, 2016
Sponsor:
Information provided by (Responsible Party):
Egalet Ltd

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.

Condition or disease Intervention/treatment Phase
Pain Drug: hydrocodone Drug: hydrocodone & acetaminophen combination Phase 1

Detailed Description:

Outcomes:

Pharmacokinetic parameters and bioequivalence testing.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
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.
Study Start Date : November 2008
Actual Primary Completion Date : December 2008
Actual Study Completion Date : April 2009

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Egalet® hydrocodone treatment A
Single Dose administration
Drug: hydrocodone
Extended Release tablet

Experimental: Egalet® hydrocodone Treatment B
Single Dose Administration
Drug: hydrocodone
Extended Release tablet

Experimental: Egalet® hydrocodone Treatment C
Single Dose Administration
Drug: hydrocodone
Extended Release tablet

Experimental: Egalet® hydrocodone Treatment D
Single Dose Administration
Drug: hydrocodone
Extended Release tablet

Active Comparator: Active Comparator
Single Dose Administration
Drug: hydrocodone & acetaminophen combination
Immediate Release tablet, hydrocodone and acetaminophen combination product




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00802087


Locations
Canada, Quebec
Montreal, Quebec, Canada
Sponsors and Collaborators
Egalet Ltd
Investigators
Study Director: Christine Andersen, M.Sc.Pharm Egalet A/S

Responsible Party: Egalet Ltd
ClinicalTrials.gov Identifier: NCT00802087     History of Changes
Other Study ID Numbers: HC-EG-001
First Posted: December 4, 2008    Key Record Dates
Last Update Posted: August 29, 2016
Last Verified: August 2016

Keywords provided by Egalet Ltd:
Hydrocodone
Pharmacokinetics
Safety & Tolerability

Additional relevant MeSH terms:
Hydrocodone
Acetaminophen
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Antitussive Agents
Respiratory System Agents