ACTRN12615000925549已完成1 期
A Phase 1 Crossover Study to Evaluate the Pharmacokinetics (PK), Pharmacodynamics (PD) and Safety of Two Formulations of a 7-Day Application Donepezil Transdermal Delivery System (TDS) Compared to Oral Administration of Aricept (Registered Trademark) in Healthy Volunteers
INCResearch Australia Pty Ltd0 个研究点目标入组 36 人开始时间: 2015年9月4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
- 36
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 50 Years 至 80 Years（—）
- 性别
- All
入选标准
- •Has a Body Mass Index (BMI) between 18-32 kg/m2 (inclusive) as calculated using the site standard procedures.
- •- Willing and able to discontinue all nonsteroidal anti-inflammatory drugs (NSAID) or COX-2 analgesic therapy, thirty days prior to Day 1 and until completion of the Study Exit Visit. This includes over-the-counter (OTC) pain medications and topical analgesics that contain an NSAID or COX-2. The use of NSAIDs or COX-2 medications at any time during the study and through to completion of the Study Exit Visit is prohibited and contraindicated.
- •- If the subject is receiving allowed medications for the treatment of non-excluded medical conditions, the dose must be stable for at least twenty eight days before randomization on Day 1. Permitted medications must be consistent with the current label for oral donepezil (Aricept) tablets.
- •- Women and men of child-bearing potential must agree to use adequate contraception prior to study entry, for the duration of study participation, and for ninety days following completion of therapy. Postmenopausal status will be verified by the absence of the menstrual cycle for twelve consecutive months or medical documentation of an oophorectomy or hysterectomy or bilateral tubal ligation and follicle-stimulating hormone (FSH) blood test at screening. FSH must be > 25.8 mIU/mL.
排除标准
- •- Plasma donation within twenty eight days of screening or any blood donation or blood loss > 500 mL within three months of screening.
- •- Unwilling to abstain from new strenuous physical exercise and from alcohol consumption for forty eight hours prior to scheduled PK blood draws at the clinic visits (subjects can maintain their normal exercise routine).
- •- Has cuts, scratches/abrasions, scars, breaks in the skin surface, recent tattoos (within last six months) at the application site, skin with excessive hair, indications of sunburn, excessive skin tanning, stretch marks and/or similar abnormalities at the intended application sites which would affect absorption of the Investigational Product.
- •- Must refrain from using tanning salons, saunas, or sun bathing during the conduct of the study. Must also avoid shaving of application site, waxing of application site, or use of lotion hair remover on or near application site from 48 hours before patch application and during the conduct of the study.
- •- Must abstain from food or beverages containing grapefruit, starfruit, pomegranate, limes, seville oranges, pomelo and food or beverages containing > 5% the aforementioned fruits (examples are: fruit drinks, fruit punches, fruit cocktails, fruit aides) fourteen days prior to the first patch application and throughout the study.
- •- Has a history of or is currently consuming high caffeine levels (greater than ten regular or espresso cups of coffee per day) and/or smoke more than twenty cigarettes per day for more than ten years (ex-smokers can be included in the study if they ceased smoking at least one year from the start of the study)
- •- Significant cardiovascular disease, including moderate or severe congestive heart failure (ejection fraction of < 40%) or clinically significant stenosis or occlusion of a carotid or vertebral artery
- •- Diabetes complicated with retinopathy (by history), neuropathy (by history or physical examination), or nephropathy (by serum creatinine > ULN or proteinuria > 0.2 g/L). Uncomplicated, stable diabetes that is well controlled and actively managed is not exclusionary.
- •- Potential for occupational exposure to anticholinesterase agents in the three weeks prior to randomization or prior to the planned Study Exit Visit
- •- Have a history of allergic reactions to medical grade adhesive tapes, sunscreens, cosmetics, lotions, fragrances, or latex.
- •- Use of adjuvant analgesics, including antidepressants, anticonvulsants, selective serotonin re-uptake inhibitors (SSRIs) and serotonin-norepinephrine re-uptake inhibitors (SNRIs). The use of antidepressant therapy for depressive illness is permitted if judged to be clinically acceptable by the Investigator.
- •- Use of any topical products without medicinal ingredient (including but not limited to perfumes, body lotions, sunscreens, spray or patch oils, creams and alcohol) on the area intended for patch application within forty eight hours prior to the first patch application until after the last sample collection of each period. Topical application of products without significant systemic absorption are allowed in areas other than the ones intended for patch application
- •- Use of food or beverages containing xanthine derivatives, xanthine-related compounds and/or energy drinks from forty eight hours prior to each patch application until after the last pharmacokinetic blood sample of each treatment period
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