Healthy female
Conditions
Interventions
1.Measurement of urethral, bladder and rectal pressure in response to transcranial and sacral root magnetic stimulation using micro-tip transducer catheter or liquid filling catheter. 2.Administratio
Sponsors
Medical Co. LTA Nishikumamoto Hospital
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. In the opinion of the investigator or the subinvestigator, the subject is capable of understanding and complying with protocol requirements. 2. The subject, who signed the written informed consent, is not pregnant or lactating. 3. The subject is aged 20 to 55, inclusive, at the time of signing the informed consent form. 4. The subject weights at least 45 kg and has BMI between 18.0 and 30.0 kg/m2, inclusive, at Screening. 5. The subject is free of clinically problematic abnormalities in accordance with the criteria of the study site and is judged eligible to participate in this study by the investigator. 6. A subject of childbearing potential who is sexually active with a nonsterilized male partner agrees to use routinely adequate contraception from signing of informed consent throughout the duration of the study and 4 weeks (28 days) after the last dose of study medication.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reproducibility of the test results reported by Dr. Schurch et al. | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety of magnetic stimulator, urodynamics equipment, and administration of Duloxetine. Accuracy of established method for measuring urethral sphincter contraction and urethral pressure. | — |
Countries
Japan
Contacts
Public ContactMakoto Yono
Medical Co. LTA Nishikumamoto Hospital Clinical Pharmacology Department
Outcome results
None listed