EUCTR2007-005486-34-AT进行中（未招募）不适用
A Pilot Study to Evaluate the Relative Bioavailability of Diclofenac as Measured by Microdialysis After Repeated Doses of Two Topical Diclofenac Formulations - A Pilot Study to Evaluate the Relative Bioavailability of Two Topical Diclofenac Formulations
GlaxoSmithKline Consumer Healthcare0 个研究点开始时间: 2008年4月7日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •1)Subject is a healthy male Caucasian between 18 - 55 years of age (inclusive).
- •2)Subject has a body mass index between 20 - 30kg/m2 (inclusive).
- •3)Subject is in good general health with (in the opinion of the investigator) no clinically significant and relevant abnormalities as assessed by medical history, physical examination, vital signs, 12-lead ECG, and clinical laboratory tests.
- •4)Subject understands and is willing, able, and likely to comply with all study requirements, procedures, and restrictions.
- •5)Subject demonstrates a willingness to participate as evidenced by voluntary written informed consent.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years)
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1)Subject has any clinically relevant acute or chronic disease, which could interfere with his safety during the clinical trial or expose him to undue risk through the participation in the trial or which could interfere with the study objective.
- •2)Subject has a known history or presence of cardiac, pulmonary, gastrointestinal, endocrine, musculoskeletal, neurological, hematological, liver, kidney or other disease, unless deemed not clinically significant by the investigator.
- •3)Subject has significant physical or organ abnormality.
- •4)Subject has a skin disease and/or skin abnormalities (e.g. dermatitis, eczema, psoriasis, significant dryness, skin lesions) at or near the site of drug application.
- •5)Subject has known skin sensitivity to topical applications.
- •6)Subject has any clinically significant allergy or history of severe allergic reaction, especially skin allergies.
- •7)Subject has drug hypersensitivity or known hypersensitivity to diclofenac, NSAIDs, or aspirin (e.g., asthma).
- •8)Subject has a psychiatric illness.
- •9)Subject has current or recent history of abuse or addiction (alcohol, drugs or substances).
- •10)Subject has participated in a clinical trial within the last 30 days prior to the first scheduled dosing of this trial.
- •11)Subject is currently using or has used within the 14 days immediately prior Visit 2, any prescription medication, over-the-counter medication, or herbal supplement.
- •12)Subject is currently using or has used within the 30 days immediately prior Visit 2, any prescription or over-the-counter medication containing diclofenac.
- •13)Subject has had blood loss of more than 450ml within the six weeks immediately prior to Visit 2 or intended blood donation within the six weeks immediately after his or her last visit.
- •14)Subject has consumed excessive amounts of caffeine judged to be excessive by investigator.
- •15)Subject requires a special diet (e.g. vegetarian diet).
- •16)Subject is an employee of the sponsor or the clinic site or members of their immediate family.
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