ACTRN12616000348459已完成1 期
A Phase 1 Parallel Study to Evaluate the Pharmacokinetics (PK),Pharmacodynamics (PD) and Safety of Formulations of a 7-Day Application DonepezilTransdermal Delivery System (TDS) in Healthy Female Volunteers
INCResearch Australia Pty Ltd0 个研究点目标入组 24 人开始时间: 2016年3月17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
- 24
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
- Female
入选标准
- •1. Caucasian female aged 50 to 80 years (inclusive) on the day of treatment allocation.
- •2. Has a Body Mass Index (BMI) between 18-32 kg/m^2 (inclusive) as calculated using the site standard procedures.
- •3. Must be willing and able to understand and participate in all scheduled evaluations by
- •providing a signed and dated written informed consent prior to the initiation of any study
- •procedures.
- •4. Women 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.
- •5. 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.
- •6. 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 treatment allocation on Day 1. Permitted medications must be consistent with the current label for oral donepezil (Aricept 'Registered Trademark) tablets.
排除标准
- •1. Dosing with an investigational product within sixty days prior to screening.
- •2. Plasma donation within twenty eight days of screening or any blood donation or blood loss > 500 mL within three months of screening.
- •3. Has skin color or tone that may not allow reliable evaluation of irritation.
- •4. 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).
- •5. Has intolerance to venipuncture and/or inability to comply with the extensive blood
- •sampling required for this study or does not have suitable veins in both arms.
- •6. 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.
- •7. 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.
- •8. 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.
- •9. Subjects with a history of or who are currently consuming high caffeine levels (greater
- •than ten regular or espresso cups of coffee per day); heavy smokers who smoke more
- •than twenty cigarettes per day. Exception will be made for lighter smokers and subjects
- •on stable doses of nicotine patches.
- •10. Presence of any major psychiatric disorder if, in the opinion of the Investigator, the
- •psychiatric disorder or symptom is likely to confound interpretation of drug
- •effect/tolerability, or affect the subject’s ability to complete the study.
- •11. 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.
- •12. Significant or chronic lung disease, including Chronic Obstructive Pulmonary Disease
- •(COPD) and severe or unstable asthma.
- •13. 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.
- •14. Known or suspected systemic infection, including human immunodeficiency virus (HIV),
- •hepatitis B virus (HBV) or hepatitis C virus (HCV), or tuberculosis (TB) or qualitative
- •syphilis test as judged by the Investigator at screening.
- •15. History of severe allergy/hypersensitivity reactions or on-going allergy/hypersensitivity
- •reactions, or history of hypersensitivity to donepezil or other drugs of the cholinesterase
- •inhibitor class.
- •16. Potential for occupational exposure to anticholinesterase agents in the three weeks prior to treatment allocation or prior to the planned Study Exit Visit
- •17. History of cancer within five years of screeni
研究者
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