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The effect of a single dose of WH138 on urinary sodium excretion in adult males. -An open-label, dose-escalation study-

The effect of a single dose of WH138 on urinary sodium excretion in adult males. -An open-label, dose-escalation study- - Interventional study of WH138 on adult males

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000047118
Enrollment
12
Registered
2023-05-31
Start date
2022-03-18
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

Adults

Interventions

Period 1 (No intake) Period 2 (WH138, Low-dose, single dose administration) Period 3 (WH138, High-dose, single dose administration)

Sponsors

Otsuka Pharmaceutical Co., Ltd
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: 1) Subjects who are voluntarily giving written informed consent. 2) Adult males aged between 20 and 65 3) Subjects who can take meals, take urine samples and keep a resting state on the schedule indicated by investigators.

Exclusion criteria

Exclusion criteria: 1) Subjects who have possibilities for allergy related to the test food 2) Subjects whose clinical inspection results are estimated inappropriate to this study by principal investigator. 3) Subjects who have or had disorder in digestive, circulatory or endocrine system and who are estimated inappropriate to this study by principal investigator. 4) Subjects who are excess of daily salt intake. 5) Subjects who are estimated inappropriate to participate to this study by principal investigator.

Design outcomes

Primary

MeasureTime frame
Urinary sodium excretion and urine volume Urinary WH138 excretion

Countries

Japan

Contacts

Public ContactAyuko Oyama

Otsuka Pharmaceutical Co., Ltd Saga Nutraceuticals Research Institute

Oyama.Ayuko@otsuka.jp0952-52-1522

Outcome results

None listed

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