healthy volunteers none
Conditions
Interventions
Trade Name: NARCAN
Product Name: NALOXONE HYDROCLORIDE
Product Code: V03AB15
Pharmaceutical Form: Intravenous infusion
INN or Proposed INN: NALOXONE HYDROCHLORIDE
CAS Number: 357-08-4
Other descriptiv
Sponsors
None listed
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Healthy volunteers (18-45 years) who have no bowel symptoms and who are in good general health are eligible for the study. 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 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: They have relevant underlying disease (cardia, pulmonary, metabolic, kidney or liver disease, …) • They have a history of esophageal or gastric surgery, or recurrent or intermittent upper gastrointestinal symptoms (upper abdominal pain, nausea, vomiting, bothersome fullness or early satiation, heartburn, regurgitation,…) • They have a history of allergy to several types of drugs or food. • They have ever been treated for depression • There is a possibility of becoming pregnant during the study period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: In order to investigate whether central or peripheral mu-opioid receptors control the interdigestive motor activity of the proximal gastrointestinal tract, hunger scores and plasma gastrointestinal hormone levels in man we set out to compare the effect of naloxone vs. methylnaltrexone during a small bowel manometry experiments to be taken four times: After an overnight fast a SB manometry study will be taken. Twenty minutes after the passage of a spontaneous phase 3, methylnaltrexone or saline, naloxone or saline will be administered. Motility recording will be continued until the passage of 2 more activity fronts or for a maximum of 34 hours after drug administration. During throughout the study hunger scores asssessd by VAS questionnaire and plasma ghrelin, motilin and obestatin levels will be collected. ;Secondary Objective: none;Primary end point(s): role of peripheric opioid receptors on interdigestive gastrointestinal motility and hunger. | — |
Countries
Belgium
Outcome results
None listed