Naloxone and Intravenous Methylnaltrexone Effects on Bladder Function

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

Summary

This is a double-blind, randomized, study at a single clinical site investigating the effect of methylnaltrexone and naloxone versus placebo in healthy males who have received a short-acting opioid, remifentanil.

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

Details

• Lead Sponsor: Bausch Health Americas, Inc.; Valeant Pharmaceuticals International, Inc.
• Treatments: Methylnaltrexone; Naloxone; Naltrexone

Criteria

Inclusion Criteria:

1. Healthy males, 18 to 65 yrs with normal urinary function

2. Body weight less than 150 kg and Body Mass Index between 20-32.

Exclusion Criteria:

1. Females

2. History of drug or alcohol abuse

3. History of significant chronic illness (cardiovascular, gastrointestinal, pulmonary, neurologic, endocrine, renal, hepatic, etc.)

4. Subjects who received opioids for one week or longer in the last 2 months.