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临床试验/NCT01206985
NCT01206985已完成1 期

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

University Hospital, Clermont-Ferrand2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2010年10月1日最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
发起方
入组人数
20
试验地点
2
主要终点
Change in pain threshold testing mechanical stimulation (von Frey electronic)

研究概览

简要总结

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.

详细描述

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

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Double (Participant, Care Provider)

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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. ..).

结局指标

主要结局

Change in pain threshold testing mechanical stimulation (von Frey electronic)

时间窗: T0-5min, T0+3min, T0+7min, T0+15min, T0+30min, T0+50min, T0+90min

次要结局

  • Evaluation of the acceptability of the permucosal product by the subject (evaluation questionnaire).(T0+70min)
  • Analysing a Sample of saliva for enzymatic determination (pharmacogenomics analysis)(T0-10min)

研究者

发起方
University Hospital, Clermont-Ferrand
申办方类型
Other
责任方
Sponsor

研究点 (2)

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