JPRN-UMIN000009096已完成未知
Establishment of the Method for Measuring Urethral Sphincter Contraction and Urethral Pressure in Response to Transcranial and Sacral Root Magnetic Stimulation, and the Evaluation of the Effect of a Single Oral Dose of Duloxetine on Urethral Pressure in Healthy Adult Japanese Females - Establishment of the Method for Measuring Urethral Sphincter Contraction and Urethral Pressure in Response to Transcranial and Sacral Root Magnetic Stimulation, and the Evaluation of the Effect of a Single Oral Dose of Duloxetine on Urethral Pressure
Medical Co. LTA Nishikumamoto Hospital0 个研究点目标入组 20 人开始时间: 2013年9月17日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 20
研究概览
简要总结
Oral administration of duloxetine significantly increased the mean and maximal urethral closure pressures at the rest over the proximal and middle third of the urethra. During coughing, duloxetine marginally significantly increased the mean distal urethral pressure and significantly reduced the mean delay in the distal urethral pressure peak relative to the vesical peak. Although duloxetine did not change amplitudes of pressure spikes in response to SMS, this drug significantly lowered the MT in response to TMS.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 20years-old 至 55years-old（—）
- 性别
- Female
入选标准
- 未提供
排除标准
- •The subject who; 1.received study drug within 16 weeks before participation in this study. 2.is an immediate family member, study site employee, or in a dependant relationship with a study site employee who is involved in the conduct of this study or may consent under duress. 3.with a history of disease considered to be unsuitable for this study. 4.with a history of convulsive disease such as epilepsy. 5.is carrying an implant type medical device. 6.has an indwelling magnetic body in the cranial cavity. 7.with a history of gastrointestinal surgery that may affect the drug absorption. 8.has chronic urinary tract infection or has had a recent episode within 4 weeks of Check-in or evidence of current urinary tract infection. 9.has a known hypersensitivity to any related compounds of Duloxetine and other drugs. 10.has a history of alcohol abuse within 52 weeks prior to Screening or is unwilling to agree to abstain from alcohol throughout the study. 11.has a positive test result for hepatitis B surface antigen, hepatitis C antibody, human immunodeficiency virus antibody/antigen or serological reaction of syphilis at Screening. 12.is excessively smoking routinely (unable to refrain from smoking during the hospitalization). 13.has undergone blood component donation within 2 weeks, or has undergone whole blood collection. of at least 200 mL within 4 weeks or at least 400 mL within 12 weeks prior to Check-in. 14.has a QTcF >470 ms or PR outside the range 120 to 220 ms, based on the mean of ECG values at Screening. 15.has a supine blood pressure outside the ranges of 90 to 140 mm Hg for systolic and 50 to 90 mm Hg for diastolic at Screening. 16.has a heart rate outside the range 40 to 100 bpm at Screening. 17.who is unlikely to comply with the protocol or is unsuitable for any other reason in the opinion of the investigator or the subinvestigator.
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