Pharmacokinetics of Fentanyl Following Intravenous and Oral Routes of Administration in Healthy Volunteers

• Status: Completed
• Trial end date: 2003-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to compare the pharmacokinetics of fentanyl following i.v. and oral administration in healthy volunteers, and to assess the bioavailability of fentanyl following oral administration. Moreover, safety is assessed.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Alza Corporation, DE, USA
• Treatments: Citric Acid; Fentanyl; Naloxone; Naltrexone

Criteria

Inclusion Criteria:

• 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

• And who had, after sitting for 5 minutes, blood pressure between the ranges of 100 to 150 mm Hg systolic and 50 to 90 mm Hg diastolic. Any decrease in systolic blood pressure after standing for 2 minutes had to be less than or equal to 20 mm Hg

Exclusion Criteria:

• History of chronic obstructive pulmonary disease or any other lung disease, such as asthma, that would cause carbon dioxide retention

• Known allergy or hypersensitivity to fentanyl or other opioids, naltrexone or naloxone

• Usage of prescription medication (except for birth control medications, sex-hormone replacement or vitamins) within 14 days before Day 1, monoamine oxide inhibitors within 21 days prior to Day 1, over-the-counter medication (except for vitamin supplements or acetaminophen less than 2 gm/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)