Pilot Study of Pharmacology of Paracetamol Administered Per-oral Mucosa (PMB)

University Hospital, Clermont-Ferrand

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: Placebo

Drug: Kinetics of plasma concentrations of paracetamol

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00982215

CHU-0057

Details and patient eligibility

About

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.

Full description

Pilot study of Pharmacology Paracetamol administered per-oral mucosa PMB. Crossover study, double-blind, randomized, controlled versus placebo.

Enrollment

20 patients

Sex

Male

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
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 criteria

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)