ACTRN12620000199910已完成1 期
A Phase 1, Randomized, Blinded, 2-Way Crossover Study to in Healthy Volunteers to Assess the Relative Bioavailability of Corplex (TM) Donepezil Transdermal Delivery Systems With and Without Crystals
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Corium Inc.
- 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
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •Key inclusion criteria include:
- •1.Healthy, adult, male or female, at least 18 years of age at Screening
- •2.Nonsmoker or occasional smoker (less than or equal to 1 cigarette or equivalent/day) and must agree not to smoke or agree to consume no more than 1 cigarette or equivalent/day from the Screening Visit until after the End of Study Visit.
- •3.Body mass index between 18.0 and 32.0 kg/m2 at Screening.
- •4.Sparse, minimal, and fine hair on skin at application sites
- •5.If a female of childbearing potential: must be either sexually inactive (abstinent) for at least 14 days prior to the first TDS application and remain sexually inactive throughout the study or be using an acceptable birth control methods while within the study
- •6.A female of nonchildbearing potential: defined as either postmenopausal with amenorrhea for at least 1 year prior to Screening AND have an acceptable follicle-stimulating hormone serum level, or have official documentation of at least 1 of the sterilization procedure no less than 6 months prior to Screening.
- •7.For a male: must agree to an acceptable birth control methods from Screening until after the End of Study Visit
排除标准
- •Key exclusion criteria include:
- •1.History of any clinically significant medical or psychiatric condition or disease that, in the opinion of the investigator, might confound the results of the study or poses an additional risk to the subject by participation in the study.
- •2.History of alcoholism or drug abuse within the past 2 years prior to the first study product treatment, or current alcohol or drug abuse.
- •3.History of significant multiple, severe contact allergies or has had 1 or more anaphylactic reactions, or is significantly intolerant to prescription or nonprescription drugs.
- •4.Exhibiting symptoms suggestive of bladder outflow obstruction as assessed by the investigator.
- •5.Has intolerance to venipuncture and/or inability to comply with the extensive blood sampling required for this study or does not have suitably intact veins in both arms.
- •6.Potential for occupational exposure to anticholinesterase agents in the 5 weeks prior to Screening through the last TDS removal.
- •7.Female subjects with a positive pregnancy test or who are lactating
- •8.History or presence of hairy skin on application sites that may potentially interfere with TDS adhesion and drug absorption. Clipping is permitted to remove fine or sparse hair. Subjects with heavy hair growth at the application site will not be eligible even with clipping.
- •9.History or presence of significant skin damage, diffuse skin diseases, scars, tattoos on the application sites, or other skin disturbances or coloration that would interfere with placement of test articles, skin assessment, or reactions to drug as deemed by the investigator to potentially interfere with drug absorption or irritation assessments; subjects with a spray tan applied less than 30 days prior to study dose are excluded.
- •10.History or presence of significant dermatological disease or condition, such as atopy, psoriasis, vitiligo or conditions that are known to alter the skin appearance or physiologic response
- •11.History of or current consumption of high levels of caffeine (equivalent to 3 regular cups of coffee or 2 energy drinks, per day).
- •12.Donation of blood or significant blood loss within 56 days prior to the first study product treatment.
- •13.Plasma donation within 7 days prior to the first study product treatment.
- •14.Use of donepezil HCl or related drugs within 60 days prior to the first study product treatment.
- •15.Clinically significant depression symptoms or suicidal ideation or behavior
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