Study on BE study designing under low-gastric acid condition using gastric acid secretion inhibitor. Study1:To investigate timing of PPI single dose. Study2:To investigate dose frequency of H2 blocker.

Study on BE study designing under low-gastric acid condition using gastric acid secretion inhibitor. Study1:To investigate timing of PPI single dose. Study2:To investigate dose frequency of H2 blocker. - Evaluation of gastric pH changes after administration of PPI or H2 blocker.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000013379

Enrollment

Registered

2014-03-10

Start date

2014-03-10

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

Gastric Ulcer

Interventions

Study1: To administer oral dose of sodium rabeprazole and monitor gastric pH for 24 hours. Study2: To administer oral dose of famotidine and monitor gastric pH for 24 hours.

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: 1, Healthy Japanese male subjects who provide signed written informed consent. 2, Subjects between 20 and 40 (inclusive) year of age at the time of consent. 3, Subjects with BMI <=18.5 and >25.0 at the time of screening. 4, Subjects judged as adequate for this study by study physician.

Exclusion criteria

Exclusion criteria: 1, Subjects with present illness which requires treatment. 2, Subjects with past medical history which was considered not adequate for this study. 3, Subjects with past history of drug allergy. 4, Subjects who took prescribed medicine and/or OTC drug 1 week prior to admission of period 1. 5. Subjects who donated and/or withdrawn whole blood more than 400mL within 12 weeks, 200mL within 4 weeks, and/or blood component within 2 weeks prior to admission of period 1. 6, Subjects who participated in a clinical trial and was administered study drug. 7, Subjects with history of alcohol and/or drug abuse. 8, Subjects who was judged not appropriate for this study by study physician.

Design outcomes

Primary

Measure	Time frame
Study1: 24 hour intragastric pH after administration of sodium rabeprazole Study2: 24 hour intragastric pH and pharmacokinetics after administration of famotidine.	—

Countries

Japan

Contacts

Public ContactMasanari Shiramoto

Medical Co. LTA Clinical Pharmacology Center Hakata Clinic Clinical Pharmacology Department

masanari-shiramoto@lta-med.com0922837701

Outcome results

None listed

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