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The effect of test food on night-time urinary electrolyte excretion and pharmacokinetics of the metabolites in healthy volunteers

The effect of test food on night-time urinary electrolyte excretion and pharmacokinetics of the metabolites in healthy volunteers - The effect of test food on night-time urinary electrolyte excretion in healthy volunteers

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000030411
Enrollment
20
Registered
2019-04-01
Start date
2017-12-16
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 Volunteer

Interventions

Placebo(single ingestion) - washout period - test food(single ingestion) Test food(single ingestion) - washout period - Placebo(single ingestion)

Sponsors

Otsuka Pharmaceutical Co., Ltd
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1)Healthy males aged between 30 and 64. Healthy post-menopausal females aged between 50 and 64 with no menstruation in the past 12 months. 2)Subjects who 24hr Urinary sodium in screening examination is lower. 3)Subjects who routinely not take medicine, supplements, FOSHU, and/or health food which affect to the result of the study.

Exclusion criteria

Exclusion criteria: 1) Subjects who have allergy to medicinal and foods. 2) Subjects who has under treatment or a history of serious disease (e.g., diabetes, liver disease, kidney disease, or heart disease). 3) Subjects who systolic blood pressure is more than 140 mmHg or diastolic blood pressure is more than 90 mmHg. 4) Subjects who BMI is more than 30 kg/m2. 5) Subjects who make a blood donation of 400 ml within 12 weeks before the start of the intake or that of 200 ml within 4 weeks before the start of the intake. 6) Subjects who are estimated inappropriate to participate to this study by principal investigator.

Design outcomes

Primary

MeasureTime frame
Urinary electrolyte

Countries

Japan

Contacts

Public ContactTsuneyuki Noda

Otsuka Pharmaceutical Co., Ltd. Saga Nutraceuticals Research Institute

Noda.Tsuneyuki@otsuka.jp0952-52-1522

Outcome results

None listed

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