臨床研究等提出・公開システム

Date of registration	Dec. 24, 2025
Last modified on	Aug. 05, 2026
Trial ID	jRCT2031250597

Scientific Title	A single-dose study of HP-3180
Public Title	A single-dose study of HP-3180

Contact for Scientific Queries	Name	Yusuke Tanaka
	Affiliation	Hisamitsu Pharmaceutical Co., Inc.
	Address	2-4-1 Marunouchi, Chiyoda-ku, Tokyo
	Telephone	+81-3-5293-1734
	E-mail	shikenjoho@hisamitsu.co.jp
Contact for Public Queries	Name	Clinical Development Department Contact for Clinical Trial Information
	Affiliation	Hisamitsu Pharmaceutical Co., Inc.
	Address	2-4-1 Marunouchi, Chiyoda-ku, Tokyo
	Telephone	+81-3-5293-1734
	E-mail	shikenjoho@hisamitsu.co.jp

Recruitment status	Not Recruiting

Anticipated date of first enrollment		Jan. 06, 2026
Actual date of first enrollment		Jan. 06, 2026
Target sample size		48
Study Type		Interventional
Study Design	allocation	non-randomized controlled trial
	masking	open(masking not used)
	control	active control
	assignment	crossover assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	- Healthy Japanese adult females aged >=18 and <=35 years - Subjects weighting 40 kg or more
	Exclusion Criteria	- Subjects who received any drug within 1 week prior to administration of the investigational product - Subjects who took any drug considered to affect drug metabolism within 4 weeks prior to administration of the investigational product
	Age Minimum	18age old over
	Age Maximum	35age old under
	Gender	Female
Health Condition(s) or Problem(s) Studied		Healthy adult
Intervention(s)		Step1: a single dose of HP-3180 Dose 1 will be administered. a single dose of control drug will be administered. Step2: a single dose of HP-3180 Dose 2 will be administered. Step3: a single dose of HP-3180 Dose 3 will be administered.
Primary Outcome(s)		Pharmacokinetics, Safety

Primary Sponsor	Hisamitsu Pharmaceutical Co., Inc.

Secondary Sponsor

Secondary Sponsor

Name of Certified Review Board	Review Board of Human Rights and Ethics for Clinical Studies Institutional Review Board
Address	2-2-1, Kyobashi, Chuo-ku, Tokyo
Telephone	+81-3-6605-0572
E-Mail	soudan@hurecs.org
Approval Status	Approval

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
3	Aug. 05, 2026	(this page)	Changes
2	Mar. 09, 2026	Detail	Changes
1	Dec. 24, 2025	Detail

List of change history