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Pharmacokinetics of SNR15 and Urinary electrolyte excretion in Healthy Volunteers: A randomized, double-blind, placebo-controlled crossover study

Pharmacokinetics of SNR15 and Urinary electrolyte excretion in Healthy Volunteers: A randomized, double-blind, placebo-controlled crossover study - Pharmacokinetics study of SNR15

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000024719
Enrollment
24
Registered
2017-12-18
Start date
2016-11-05
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 - SNR15 A (single ingestion) - washout period - SNR15 B (single ingestion) SNR15 A (single ingestion) - washout period - SNR15 B (single ingestion) - washou

Sponsors

Otsuka Pharmaceutical 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 who routinely do 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 4weeks before the start of the intake. 6)Subjects who are estimated inappropriate to this study by principal investigator.

Design outcomes

Primary

MeasureTime frame
Plasma concentration of SNR15 metabolite

Secondary

MeasureTime frame
Plasma concentration of SNR15 Urinary electrolyte excretion

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