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

NCT00714558 | Completed Phase 1

• 1 other identifier: CR003253
• Study Type: interventional
• Target: 18
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Biological Availability

Keywords

Pharmacokinetics; Administration, Oral; Naltrexone; Biological Availability; Infusions, Intravenous; Fentanyl; Safety; Naloxone

Outcome Measures

Primary Outcomes (1)

• Evaluate the pharmacokinetics of fentanyl citrate following i.v. and oral routes of administration in healthy volunteers, and to assess the absolute bioavailability of fentanyl citrate following oral administration.

Secondary Outcomes (1)

• Assessment of safety. Vital signs, Physical examination, clinical laboratory tests, and electrocardiogram were performed at screening and study termination. Additionally, vital signs were recorded on Days 1 and 2 of both treatment periods.

Interventions

Fentanyl citrate; Naltrexone; Naloxone DRUG

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Alza Corporation, DE, USA: lead

Related Links

• Pharmacokinetics of fentanyl following intravenous and oral routes of administration in healthy subjects

MeSH Terms

Interventions

Fentanyl; Naltrexone; Naloxone

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Alza Corporation Clinical Trial

  Alza Corporation, DE, USA

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 10, 2008
• First Posted: July 14, 2008
• Study Start: April 1, 2003
• Study Completion: May 1, 2003
• Last Updated: May 19, 2011

Record last verified: 2010-04