A Single-center, Randomized, Double-blind, Placebo-controlled Trial to Assess the Safety, Tolerability, and Pharmacokinetics of Multiple Ascending Oral Doses of OPC 39436 Spray-dry Tablets in Healthy Elderly Subjects
Phase 1
Completed
- Conditions
- Healthy Elderly Volunteer
- Registration Number
- JPRN-jRCT2080222928
- Lead Sponsor
- Otsuka Pharmaceutical Co., Ltd.
- Brief Summary
Fourteen-day multiple oral administration of OPC-39436 SD tablets at doses of 250 and 500 mg BID was confirmed to be well tolerated in healthy elderly subjects.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 24
Inclusion Criteria
Healthy Volunteer
- BMI: more than 18.5, under 30.0
- Body weight of at least 50 kg
- At least 1 year after menopause (for females)
Exclusion Criteria
- Existing or previous hypersensitivity to any prescription or over-the-counter (OTC) drug
- History of drug and/or alcohol abuse
- Smoking or use of tobacco products within 60 days prior to screening
- Use of any other investigational drug within 90 days prior to start of IMP administration in the present trial
- History of mental disorder
and so on.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method