DRKS00012706已完成4 期
An exploratory pilot study in healthy volunteers to assess the parameters for the design of bioequivalence studies on moderately lipophilic,moderately to highly protein bound drugs using dermal open flow microperfusion (dOFM) - FDA02_AIM2_Pilot
HEALTH – Institute for Biomedicine and Health Sciences, JOANNEUM RESEARCH Ges.mbH,0 个研究点目标入组 6 人开始时间: 2017年7月28日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 6
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
- N/a: Single Arm Study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 65 Years（—）
- 性别
- All
入选标准
- •18 to 65 years inclusive,
- •Males and/or non-pregnant, non-breastfeeding females (subjects need to be informed about adequate contraceptive methods).
- •Able to read, understand, and sign the written informed consent form.
- •Willing to follow the protocol requirements and comply with protocol restrictions.
排除标准
- •Smoker who is not willing to restrain from smoking during the in-house-visit (Visit 2).
- •History of drug and/or alcohol abuse within one year of start of study as judged by the investigator.
- •Tattoos or broken and/or damaged skin at the application areas.
- •Active skin diseases like psoriasis or atopic dermatitis.
- •Not willing to avoid excessive sun exposure, steam baths, sauna, swimming and other strenuous activities between Visit 2 and the End-of-Study examination
- •Not willing to refrain from shaving the anterior of the thighs or using skin care products on the anterior of the thighs for at least 5 days prior to start of Visit 2.
- •Pronounced hairiness on the thighs that may negatively affect BE testing.
- •Known allergy/hypersensitivity to any of the materials/supplies used during the study.
- •Presence of needle phobia.
研究者
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