Status:
COMPLETED
Pharmacokinetics of Naltrexone Following Intravenous and Oral Routes of Administration in Healthy Volunteers
Lead Sponsor:
Alza Corporation, DE, USA
Conditions:
Biological Availability
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief Summary
The purpose of the study is to compare the pharmacokinetics of naltrexone following i.v. and oral administration in healthy volunteers, and to assess the bioavailability of naltrexone following oral a...
Detailed Description
Naltrexone blocks the effects of opioid (morphine-like) drugs by competitive binding at the opioid receptors in the brain. Naltrexone does not possess morphine-like properties and exhibits minimal pha...
Eligibility Criteria
Inclusion
- Healthy, non smoker, men and nonpregnant nonlactating women
- Weighing a minimum of 60 kg and were within 15% of ideal weight for height as described in the Metropolitan Life Insurance Height and Weight Standards
- Who did not have a history or show presence of drug or alcohol dependence or abuse
Exclusion
- Known allergy or hypersensitivity to naltrexone
- Usage of prescription medication including opioids (except for birth control medications, sex-hormone replacement, vitamins) within 14 days prior to Day 1, over-the-counter medication (except for vitamin supplements or acetaminophen \[less than 2 g/day\]) or herbal medication within 3 days prior to Day 1, alcohol, grapefruit juice, or caffeine within 48 hours before dosing
- Consumption of more than 450 mg of caffeine per day (eg, approximately 5 cups of tea, 3 cups of regular coffee, or 8 cans of cola)
Key Trial Info
Start Date :
May 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2003
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00714584
Start Date
May 1 2003
End Date
June 1 2003
Last Update
May 19 2011
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