Effect of Extended-release Oxymorphone Taken With or Without Food on Cognitive Functioning
NCT00930943 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 30
Last updated 2023-05-09
Summary
The purpose of the study is to determine whether extended-release oxymorphone hydrochloride taken orally with a high-fat meal, generating an approximately 50% higher Cmax, impacts cognitive functioning, using Cambridge Neuropsychological Test Automated Battery (CANTAB) tests, to a greater extent than when taking under conditions of fasting.
Conditions
Interventions
- DRUG
-
Oxymorphone ER
40 mg qd twice
Sponsors & Collaborators
-
MedVadis Research Corporation
lead INDUSTRY
Principal Investigators
-
Egilius LH Spierings, MD, PhD · MedVadis Research Corporation
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2009-05-31
- Primary Completion
- 2009-11-30
- Completion
- 2009-11-30
Countries
- United States
Study Locations
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