A Phase 1 interventional study of Kinetics of plasma concentrations of paracetamol and Placebo in Healthy, sponsored by University Hospital, Clermont-Ferrand. Completed. Open to male participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-01-30.
Sponsored by University Hospital, Clermont-Ferrand · Phase 1, Interventional, and Treatment
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 oral, intravenous and rectal. The IV route allows rapid passage of paracetamol in the systemic arterial circulation and thus the brain, faster distribution evidenced a higher plasma concentration compared with oral and rectal. However the IV route also has disadvantages well known risks iatrogenic perfusion is an invasive lengthy, unpleasant and painful.
The way per-Albus not to date used for the administration of paracetamol. It is a path nonetheless very interesting for the rapid absorption of drugs such as nitrates used in angina pectoris, as it seeks a highly vascular area (the floor of the tongue or gingival groove) and allows a very rapid action. Furthermore, the terminal per-oral mucosa, less restrictive than IV administration and faster than oral administration, requires a simple medical gesture without special surveillance after administration, produces no pain or risk of infection for the patient (in contrast to the IV). It is interesting to test a new dosage form per-oral mucosa of paracetamol and compare pharmacological level (pharmacokinetics and pharmacodynamics) with the only dosage form of reference used by the IV route.
Pilot study of Pharmacology Paracetamol administered per-oral mucosa PMB. Crossover study, double-blind, randomized, controlled versus placebo.
University Hospital, Clermont-Ferrand is the lead sponsor of 841 studies on the registry; 178 are open to participants now.
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Values of vital signs before administration of the test products:
Exclusion Criteria:
Pilot study of Pharmacology Paracetamol administered per-oral mucosa PMB. Crossover study, double-blind, randomized, controlled versus placebo.
Pilot study of Pharmacology Paracetamol administered per-oral mucosa PMB. Crossover study, double-blind, randomized, controlled versus placebo.
Kinetics of plasma concentrations of paracetamol
Time frame: after administration of paracetamol
Change in pain threshold testing mechanical stimulation (von Frey electronic). Follow-up to the pain assessed by VAS (visual analog rating)
Time frame: after administration of paracetamol
Variation of the amplitude of brain wave N2P2 induced thermal stimulus at the forearm (Evoked Potentials thermal)
Time frame: after administration of paracetamol
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University Hospital, Clermont-Ferrand