Pharmacokinetic study of HP-6050 - Investigation of application site -

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2031240538

Enrollment

Registered

2025-01-17

Start date

2025-01-27

Completion date

Unknown

Last updated

2026-09-14

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

Conditions

Patients with delirium, psychomotor agitation, or irritability

Interventions

Application to site 1: A single dose of HP-6050 (Microneedle) will be applied to site 1. Application to site 2: A single dose of HP-6050 (Microneedle) will be applied to site 2. Application to site 3:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Healthy Japanese elderly subjects aged >=65 years

Exclusion criteria

Exclusion criteria: - Subjects with serious cardiovascular, renal, hepatic, neuropsychiatric, or metabolic disease, or with a history of these diseases - Subjects who received any drug within 1 week prior to the use of the investigational product - Subjects who took any drug considered to affect drug metabolism within 4 weeks prior to the use of the investigational product

Design outcomes

Primary

Measure	Time frame
Pharmacokinetics, Safety, Pharmacodynamics	—

Contacts

Public ContactContact for Clinical Trial Information Clinical Development Department

Hisamitsu Pharmaceutical Co., Inc.

shikenjoho@hisamitsu.co.jp+81-3-5293-1734

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Sep 19, 2026