Status:
COMPLETED
Paracétamol PMB by Sublingual et Buccal Routes
Lead Sponsor:
University Hospital, Clermont-Ferrand
Collaborating Sponsors:
Unither SA
Conditions:
Healthy Volunteers
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
Brief Summary
Paracetamol is the analgesic most used, indicated in the symptomatic treatment of fever and pain of mild to moderate. It comes in different dosage forms intended for oral, intravenous and rectal. The...
Detailed Description
Crossover study, double-blind, randomized, controlled versus placebo.
Eligibility Criteria
Inclusion
- Healthy volunteers.
- Aged over 18 years and not more than 50 years.
- Males or female
- Values of vital signs before administration of the test products:
- PAS between 100-140 mm Hg
- PAD between 50-90 mm Hg
- Radial pulse between 45-90 beats per minute
- Free from any treatment in the 7 days preceding inclusion including no use of analgesics or anti-inflammatories
Exclusion
- Contraindications to the administration of paracetamol
- Medical history and / or surgical judged by the investigator or his representative as being incompatible with the test, especially subjects with neuropathic pain
- Pathology evolutionary time of the review for inclusion.
- Binge drinking, smoking (more than 10 cigarettes / day), coffee, tea or drinks containing caffeine (equivalent to more than 4 cups per day) or drug abuse.
- Subject does not meet the selection criteria regarding their ability to discriminate the sensations resulting from noxious stimuli during psychometric testing.
- Topic having all breaches of the oral mucosa (aphtes. ..).
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2011
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01206985
Start Date
October 1 2010
End Date
March 1 2011
Last Update
January 30 2012
Active Locations (1)
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1
CHU Clermont-Ferrand
Clermont-Ferrand, France, 63003