ISRCTN16859029已完成2 期
A Two-part Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Applications of Four Transdermal Patch Formulations of Hyoscine and Physostigmine in Healthy Male Participants
Defence Science and Technology Laboratory (Dstl)0 个研究点目标入组 24 人开始时间: 2019年9月19日最近更新:
试验速览
- 阶段
- 2 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
入排标准
- 性别
- Male
入选标准
- •At screening for period 1:
- •1. Ability to give written informed consent prior to study participation
- •2. Healthy Caucasian male participants aged between 18 and 45 years (inclusive)
- •3. Body Mass Index (BMI) within the range of 21 and 30 kg/m2
- •4. Vital signs within the following ranges:
- •4.1 Pulse rate 40-90 bpm
- •4.2 Systolic blood pressure 90-140 mmHg
- •4.3 Diastolic blood pressure 50-90 mmHg
- •5. Ability to communicate well with the Investigator and to comply with the requirements of the study.
- •Baseline (Period 2):
- •1. Successful completion of Part 1.
- •2. Randomisation to take part in Part 2.
- •3. Willing and able to continue in the study.
排除标准
- •Does not meet inclusion criteria
研究者
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