CTRI/2009/091/000492已完成1 期
A Randomized Study Evaluating the Systemic Pharmacokinetics and Safety of Single and Multiple Diclofenac Sodium Topical Patches Following Single-day and Multiple-day Application
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Safety: To assess and compare the systemic and topical safety and tolerability of the topical patch formulation application.
研究概览
简要总结
Primary Objectives Pharmacokinetics: (1) to assess the pharmacokinetics of a diclofenac sodium topical patch with a once daily application of either one, two or four diclofenac sodium 7x10 cm, (15 mg) topical patches (total of 15, 30 or 60 mg of the sodium salt) as well as one 10x14 cm (30 mg) of the sodium salt for 4 consecutive days. Safety: to assess the systemic and topical safety and tolerability of the topical patch formulations administered once daily for 4 days consecutive.
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, variable
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Healthy male or female volunteers aged
- •Provide written informed consent to participate in all aspects of the study
- •Have a negative urine pregnancy test result, prior to study entry, for all female subjects of childbearing potential
- •Use an effective birth control method and a willingness to continue birth control during the study and for 2 weeks following the study, for female subjects of childbearing potential.
排除标准
- •A history of intolerance or hypersensitivity to aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs)
- •A history of hypersensitivity to Diclofenac or Diclofenac-containing products
- •A history of asthma within 1 year of study entry
- •A history of peptic ulcer within 1 year of study entry, any history of gastrointestinal bleeding or coagulation disorder (with the exception of bleeding due to internal or external hemorrhoids)
- •Current smoker or history of smoking within 6 months of study entry
- •Clinically significant abnormal clinical laboratory test results during screening period
- •Allergy to adhesives (e.g. adhesive tape)
- •Topical lotions, creams or gels applied to the application site within 7 days prior to randomization
- •Active skin disease involving the back (general area where patch(es) will be applied)
- •Excessive hair, abrasion, irritation, bruising, scarring or other damage to the skin of the back area
- •Any medications including prescription, over-the-counter and herbal products within 30 days prior to dosing.
- •If any medication has been used infrequently during this window, the sponsor will be contacted to determine eligibility.
- •Positive urine drug screen for any drug of abuse (including but not limited to amphetamines, cannabinoids, barbiturates, cocaine, opiates, benzodiazepines)
- •Positive alcohol breath test.
- •Subjects will be instructed to refrain from alcohol use for at least 48 hours prior to screening, and during confinement/dosing period and follow-up period.
- •Treatment with an investigational drug or device within 30 days before study entry
- •Treatment with an investigational biologic within 6 months before study entry
- •Blood donation within 30 days of enrollment
- •Any ECG abnormalities unless approved by the Medical Monitor
- •Pregnant or breast-feeding females.
结局指标
主要结局
Safety: To assess and compare the systemic and topical safety and tolerability of the topical patch formulation application.
时间窗: 4 days
次要结局
未报告次要终点
研究者
研究点 (1)
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