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| Sponsor: | University Hospital, Clermont-Ferrand |
|---|---|
| Collaborator: |
Unither Pharmaceuticals |
| Information provided by: | University Hospital, Clermont-Ferrand |
| ClinicalTrials.gov Identifier: | NCT00982215 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Healthy |
Drug: Kinetics of plasma concentrations of paracetamol Drug: Placebo |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment, Pharmacokinetics/Dynamics Study |
| Official Title: | Pilot Study of Pharmacology of Paracetamol Administered Per-oral Mucosa |
| Estimated Enrollment: | 20 |
| Study Start Date: | September 2009 |
| Estimated Study Completion Date: | March 2010 |
| Estimated Primary Completion Date: | February 2010 (Final data collection date for primary outcome measure) |
Pilot study of Pharmacology Paracetamol administered per-oral mucosa PMB. Crossover study, double-blind, randomized, controlled versus placebo.
Eligibility| Ages Eligible for Study: | 18 Years to 50 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Values of vital signs before administration of the test products:
Exclusion Criteria:
Contacts and Locations| Contact: Patrick Lacarin | placarin@chu-clermontferrand.fr |
| Principal Investigator: | Gisèle Pickering | University Hospital, Clermont-Ferrand |
More Information
| Responsible Party: | CHU Clermont-Ferrand ( Patrick Lacarin ) |
| Study ID Numbers: | CHU-0057 |
| Study First Received: | September 22, 2009 |
| Last Updated: | October 1, 2009 |
| ClinicalTrials.gov Identifier: | NCT00982215 History of Changes |
| Health Authority: | France: Ministry of Health |
|
Paracetamol per-oral mucosa PMB No disease, healthy volunteers |
|
Sensory System Agents Analgesics, Non-Narcotic Therapeutic Uses Physiological Effects of Drugs Peripheral Nervous System Agents |
Analgesics Central Nervous System Agents Pharmacologic Actions Acetaminophen |