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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

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

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2080222928
Enrollment
32
Registered
2015-07-31
Start date
2015-08-03
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Elderly Volunteer

Interventions

investigational material(s) Generic name etc : OPC-39436 INN of investigational material : - Therapeutic category code : 119 Other agents affecting central nervous system Dosage and Administration for

Sponsors

Otsuka Pharmaceutical Co., Ltd.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
safety pharmacokinetics Pharmacokinetics, Safety—

Countries

Japan

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026