ACTRN12616000349448已完成1 期
A Phase 1 Crossover Study to Evaluate the Pharmacokinetics (PK) and Safety of Two Formulations of a 7-Day Application of Memantine Transdermal Delivery System (TDS) Compared to Oral Administration of NAMENDA XR and to assess TDS adhesion in Healthy 50-80 year old Volunteers
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 48
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
- Non-randomised trial
- 主要目的
- Treatment
入排标准
- 年龄范围
- 50 Years 至 80 Years（—）
- 性别
- All
入选标准
- •Part A and B - Inclusion Criteria
- •* Caucasian male or female with light/pale skin aged 50 to 80 years (inclusive) on the day of randomization.
- •* Has a Body Mass Index (BMI) between 18-34 kg/m^2 (inclusive) as calculated using the site standard procedures.
- •* 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.
- •B. Contraception and Concomitant Medications
- •* 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.
- •* If the subject is receiving allowed medications for the treatment of non-excluded medical conditions, must be stable for at least 28 days before randomization on Day 1. Any medications not at stable dose for at least 28 days, must be discontinued with a 5 x half-life washout and Sponsor approval prior to randomization on Day 1. Permitted medications must be consistent with the current label for oral Memantine (Namenda XR) tablets.
- •* Negative urine drug screen for drugs of abuse (list as per protocol) unless there is documentation that the subject has been prescribed the corresponding medication and the medication is otherwise acceptable for the study.
排除标准
- •Exclusion Criteria
- •* Participation in another clinical study with an investigational product or device within sixty days prior to screening.
- •* Plasma donation within 28 days of screening or any blood donation or blood loss greater than 500 mL within three months of screening.
- •* Has skin color or tone that may not allow reliable evaluation of irritation.
- •* Unwilling to abstain from strenuous physical exercise and from alcohol consumption for forty eight hours prior to scheduled PK blood draws at the clinic visits.
- •* 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.
- •* 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, moles and/or similar abnormalities at the intended application sites which would affect absorption of the Investigational Product.
- •* Unwilling to refrain from using tanning salons, saunas, or sunbathe during the conduct of the study. Unwilling to also refrain from shaving of application site, waxing of application site, or using lotion hair remover on or near application site from twenty one days before patch application and during the conduct of the study.
- •* Smoke more than twenty cigarettes per day
- •B. Medical History
- •* 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.
- •* Significant cardiovascular disease, including moderate or severe congestive heart failure (ejection fraction of less than 40%) or clinically significant stenosis or occlusion of a carotid or vertebral artery.
- •* Significant or chronic lung disease, including Chronic Obstructive Pulmonary Disease (COPD) and severe or unstable asthma.
- •* Diabetes complicated with retinopathy (by history), neuropathy (by history or physical examination), or nephropathy (by serum creatinine greater than ULN or proteinuria greater than0.2 g/L). Uncomplicated, stable diabetes that is well controlled and actively managed is not exclusionary.
- •* 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.
- •* History of severe allergy/hypersensitivity reactions or on-going allergy/hypersensitivity reactions, or history of hypersensitivity to Memantine or other drugs of the N-methyl-D-aspartate (NMDA) antagonist class.
- •* History of cancer within five years of screening or between screening and randomization. Subjects with history of non-metastatic basal cell carcinoma of the skin, carcinoma in situ of the cervix or non-progressive prostate cancer may be enrolled with prior approval from Corium.
- •* Transient Ischemic Attack (TIA) or stroke in the last three years.
- •* History of suspected alcohol or drug dependence within two years of screening, or who are positive for urine drug test at the screening or one day before investigational product administration (with the exception of nicotine dependence, which is permitted).
- •* Myocardial infarction, hospitalization for unstable angina or arrhythmia or unexplained syncope within one y
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