Trials / Completed
CompletedNCT00802087
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.
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 28 (actual)
- Sponsor
- Egalet Ltd · Industry
- Sex
- All
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Accepted
Summary
The purpose of the study is to evaluate the pharmacokinetic profile of different Egalet® hydrocodone formulations and compare to a marketed hydrocodone drug.
Detailed description
Outcomes: Pharmacokinetic parameters and bioequivalence testing.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | hydrocodone | Extended Release tablet |
| DRUG | hydrocodone & acetaminophen combination | Immediate Release tablet, hydrocodone and acetaminophen combination product |
Timeline
- Start date
- 2008-11-01
- Primary completion
- 2008-12-01
- Completion
- 2009-04-01
- First posted
- 2008-12-04
- Last updated
- 2016-08-29
Locations
1 site across 1 country: Canada
Source: ClinicalTrials.gov record NCT00802087. Inclusion in this directory is not an endorsement.