Status:
COMPLETED
Pilot Study of Pharmacology of Paracetamol Administered Per-oral Mucosa
Lead Sponsor:
University Hospital, Clermont-Ferrand
Collaborating Sponsors:
Unither Pharmaceuticals
Conditions:
Healthy
Eligibility:
MALE
18-50 years
Phase:
PHASE1
Brief Summary
Paracetamol is the centrally acting analgesic most commonly used in the world, indicated for the symptomatic treatment of fever and pain in mild to moderate. It comes in different formulations for ora...
Detailed Description
Pilot study of Pharmacology Paracetamol administered per-oral mucosa PMB. Crossover study, double-blind, randomized, controlled versus placebo.
Eligibility Criteria
Inclusion
- Healthy volunteers
- Aged over 18 years and not more than 50 years
- Males
- Values of vital signs before administration of the test products:
- NOT 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
- Hypersensitivity to paracetamol
- History of hepatitis B or C
- Severe renal impairment
- Hepatic insufficiency
- 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 (aphthae)
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2009
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00982215
Start Date
September 1 2009
End Date
October 1 2009
Last Update
January 30 2012
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