Effects of THVD-201 on Pharmacokinetics and Pharmacodynamics of Tolterodine in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 18
- 主要终点
- Reductions in stimulated salivary flow (SSF)
研究概览
简要总结
THVD-201 is a novel combination of a muscarinic antagonist (tolterodine) and a muscarinic agonist (pilocarpine).
详细描述
Because of the limitations of taking two medications separated by a period of time to minimise these adverse events, two novel formulations were developed to improve compliance and ease of administration. This study will evaluate these formulations in terms of their pharmacokinetic profiles and effects on SSF. In addition, the effects of this combination and its entities on urine frequency and safety/tolerability will be assessed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy males, 18 - 45 years of age.
- •BMI 20-30 m2.
排除标准
- •Subjects who have a history of sensitivity to antimuscarinic or muscarinic agents or related derivatives.
- •Clinically significant ECG, vital signs and clinical laboratory indices.
研究组 & 干预措施
Treatment B
Study drug
干预措施: Pilocarpine (Drug)
Treatment D
Study drug
干预措施: THVD-201 (Drug)
Treatment E
Placebo
干预措施: placebo capsule (Drug)
Treatment A
Study Drug
干预措施: Tolterodine (Drug)
Treatment C
Study Drug
干预措施: THVD-201 (Drug)
结局指标
主要结局
Reductions in stimulated salivary flow (SSF)
时间窗: From Baseline
次要结局
- Determine the pharmacokinetics of tolterodine and the agonist.(From Baseline)