Paracétamol PMB by Sublingual et Buccal Routes

Healthy Volunteers Clinical Trial

Official title: Pharmacodynamic Study of 125 mg of Paracetamol Permucosal Administered by Sublingual and Buccal Route

Status Completed

Clinical Trial 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 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.

Clinical Trial Description

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy Volunteers

• NCT number: NCT01206985
• Study type: Interventional
• Source: University Hospital, Clermont-Ferrand
• Status: Completed
• Phase: Phase 1
• Start date: October 2010
• Completion date: March 2011