Paracétamol PMB by Sublingual et Buccal Routes

University Hospital, Clermont-Ferrand

Status and phase

Completed

Phase 1

Conditions

Healthy Volunteers

Treatments

Other: Von Frey electronic

Study type

Interventional

Funder types

Other

Identifiers

NCT01206985

CHU-0081

2010-018746-30 (EudraCT Number)

Details and patient eligibility

About

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 per-oral mucosal route is not used for the administration of paracetamol. It is a very interesting way 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 very rapid action. In addition, the oral administration-oral mucosa, less restrictive than IV administration and faster than oral administration, seek a single medical procedure unattended after dosing, will entail no pain or risk for infections the patient (in contrast to the IV). The investigators tested a new oral dosage form permucosal (at 250mg/ml) of paracetamol and compared at pharmacological (pharmacokinetic and pharmacodynamic) with the only dosage form of reference used by the IV route in the protocol "Pilot study Pharmacology paracetamol administered oral permucosal PMB. It seems interesting now to reduce the dose by half permucosal to assess how changing the pharmacodynamics of the form permucosal to 125mg/ml. This form will be administered in oral permucosal buccal as well as sublingual (under the pillar of the language) and compared with paracetamol in IV.

Full description

Crossover study, double-blind, randomized, controlled versus placebo.

Enrollment

20 patients

Sex

All

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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 criteria

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. ..).