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The effect of SNR15 on urinary electrolyte and the pharmacokinetics in healthy volunteers :A randomized, double-blind, placebo-controlled crossover study

The effect of SNR15 on urinary electrolyte and the pharmacokinetics in healthy volunteers :A randomized, double-blind, placebo-controlled crossover study - The effect of SNR15 on urinary electrolyte in healthy volunteers

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000029063
Enrollment
50
Registered
2018-12-18
Start date
2017-09-09
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 period (9 days) - washout period - SNR15 period (9 days) SNR15 period (9 days) - washout period - Placebo period (9 days)

Sponsors

TES Holdings Co.,Ltd
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1)Subjects who can make self-judgment and are voluntarily giving written informed consent. 2)Healthy males aged between 30 and 64. Healthy post-menopausal females aged between 50 and 64 with no menstruation in the past 12 months. 3)Subjects whose urinary sodium excretion in screening examination is low. 4)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 whose systolic blood pressure is more than 140 mmHg or diastolic blood pressure is more than 90 mmHg. 4)Subjects whose 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

Secondary

MeasureTime frame
Plasma concentration of SNR15 metabolite

Countries

Japan

Contacts

Public ContactRyoma Shimizu

TES Holdings Co.,Ltd Clinical research

r.shimizu@tes-h.co.jp03-6801-8480

Outcome results

None listed

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