CTRI/2023/10/058420已完成3 期
A Randomized, Double Blind, Placebo-Controlled, 3 Way Cross-Over Study to Demonstrate the Therapeutic Non-Inferiority of Lidocaine 2.5% and Prilocaine 2.5% Cream (Test Product) to Reference Product EMLA 5% (Lidocaine 25 mg/g and Prilocaine 25 mg/g) Cream in Male and Female Subjects Undergoing Forearm Cannulation. - Not applicable
Gracure Pharmaceuticals Ltd.0 个研究点目标入组 66 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 66
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Male or female between 18 to 65 years of age (both inclusive).
- •2. Subject who found peripheral venous cannulation painful (define as a pain recording of 25mm or greater on a 100 mm VAS for pain) without local anaesthetic.
- •3. The subject is willing to complete all the study procedures including study-related tasks, and comply with the study requirements.
- •4. Subject with the ability to read and provide written, personally signed, and dated informed consent to participate in the study.
排除标准
- •1.Subject with mental illness.
- •2.Known allergy or sensitivity to local anesthetics or hypersensitivity to lidocaine and/or prilocaine or local anaesthetics of the amide type or to any of the excipients.
- •3.Damaged or inflamed skin or open wounds at the designated application site.
- •4.Use of analgesics during the past 24 hours.
- •5.Participation in any other study during last 1 month.
- •6.Suspected lack of compliance with any requirements of the study.
- •7.Any relevant abnormalities in the routine laboratory tests.
- •9.Agitated or uncooperative subject.
- •10.Uncommunicative/deaf/mute subject.
- •11.Subject on hypnotics, or chronic pain relief medications.
- •12.Subject with hepatic impairment.
- •13.Subjects with atopic dermatitis
- •14.Subject who are on CYP450 3A4, 3A5 or 1A2-inducing or inhibiting drugs (erythromycin, ciprofloxacin, amiodarone etc.) or pharmacotherapeutic agents that affect hepatic blood flow (metoprolol) since both may affect the metabolism of lidocaine.
- •15.Subjects with defective glucose-6-phosphate dehydrogenase, hereditary or idiopathic methaemoglobinaemia.
- •16.Subjects treated with anti-arrhythmics of class III (e.g., amiodarone), methaemoglobin-inducing medicinal products (e.g. sulphonamides, nitrofurantoin, phenytoin, phenobarbital), medicinal products that reduce the clearance of lidocaine (e.g., cimetidine or betablockers).
- •17.Subjects with Class I antiarrhythmic drugs (such as tocainide and mexiletine) which can have additive and potentially synergistic toxic effects.
- •18.Females who are pregnant/planning to be pregnant/lactating or taking any oral contraceptives.
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