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Pilot Study of Pharmacology of Paracetamol Administered Per-oral Mucosa

NCT00982215 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2012-01-30

No results posted yet for this study

Summary

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.

Conditions

  • Healthy

Interventions

DRUG

Kinetics of plasma concentrations of paracetamol

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

DRUG

Placebo

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

Sponsors & Collaborators

  • Unither Pharmaceuticals

    collaborator INDUSTRY

  • University Hospital, Clermont-Ferrand

    lead OTHER

Principal Investigators

  • Gisèle Pickering · University Hospital, Clermont-Ferrand

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2009-10-31
Completion
2009-10-31

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00982215 on ClinicalTrials.gov