Plasma-concentrations of high-dose naloxone - an antidote to morphine.

Phase 1

• Conditions: Healthy subjects; MedDRA version: 17.1Level: LLTClassification code 10049475Term: Chronic painSystem Organ Class: 100000004867; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2015-000815-42-DK
• Lead Sponsor: Rigshospitalet, Copenhagen University Hospitals

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-03-06
• Last Update Posted: 3 April 2017

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Male
• Target Recruitment: Not specified

Inclusion Criteria

•Healthy male
•Age above 18 yrs and below 35 yrs
•Signed informed consent
•Urin-sample without traces of opioids (morphine, methadon, buprenorphine, codeine, tramadol, ketobemidone, oxycodone, hydromorphone, dextro-methorphan)
•American Society of Anesthesthesiologists' Physical Status score: ASA I
•Body mass index (BMI): 18 < BMI < 30 kg/m2

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 8
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Participants, who do not speak or understand Danish
•Participants, who cannot cooperate with the investigation
•Participants with pain at rest > 3 (NRS)
•Allergic reaction against morphine or other opioids (including naloxone),
•Abuse of alcohol or drugs – according to investigator’s evaluation
•Use of psychotropic drugs (exception of SSRI)
•Neurologic or psychiatric disease
•Chronic pain condition
•Regular use of analgesic drugs
•Use of prescription drugs one week before the trial
•Use of over-the-counter drugs 48 hours before the trial

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified