Clinical pharmacokinetic study of MD-352 in healthy postmenopausal female subjects
- Conditions
- healthy postmenopausal female subjects
- Registration Number
- jRCT2031250069
- Lead Sponsor
- Mochida Pharmaceutical Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- 64
-Subjects with a BMI of at least 18.5 kg/m2 and less than 25.0 kg/m2 and a body weight of at least 45 kg and less than 65 kg at screening -Postmenopausal women who have been without menstruation for 12 or more months without accompanying medical reasons
-Subjects deemed unsuitable by the principal investigator or sub-investigator -Subjects with drug hypersensitivity -Subjects who have used drugs and supplements within 7 days prior to administration of the investigational drug -Subjects with a positive result in urine drug or alcohol test -Smokers or subject with a positive result in smoking test -Subjects who have not passed 16 weeks since participation in another clinical trial
Study & Design
- Study Type
- Interventional
- Study Design
- crossover assignment
- Primary Outcome Measures
Name Time Method - -Pharmacokinetic parameters
-Adverse events
- Secondary Outcome Measures
Name Time Method