Unique ID issued by UMIN | UMIN000013379 |
---|---|
Receipt number | R000015610 |
Scientific Title | 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. |
Date of disclosure of the study information | 2014/03/10 |
Last modified on | 2014/08/19 17:21:49 |
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.
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.
Japan |
Gastric Ulcer
Gastroenterology |
Others
YES
Study1:
To investigate the influence of timing of PPI single dose confirming changes in 24 hour gastric pH, 2 x 2 cross over study.
Study2:
To investigate the influence of dose frequency of H2 blocker confirming changes in 24 hour gastric pH, 2 x 2 cross over study.
PK,PD
Study1:
24 hour intragastric pH after administration of sodium rabeprazole
Study2:
24 hour intragastric pH and pharmacokinetics after administration of famotidine.
Interventional
Cross-over
Randomized
Open -no one is blinded
Uncontrolled
2
Treatment
Medicine |
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.
20 | years-old | <= |
40 | years-old | >= |
Male
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.
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 Subjects who donated and/or withdrawn whole blood more than 400mL within 12 weeks, 200mL within 4 weeks, and/or blood component within 2 weeks prior to admission of period 1.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.
18
1st name | |
Middle name | |
Last name | Masanari Shiramoto |
Medical Co. LTA
Clinical Pharmacology Center
Hakata Clinic
Clinical Pharmacology Department
Random square 5-7 F, 6-8 Tenyamachi, Hakata-ku, Fukuoka 812-0025, Japan
0922837701
masanari-shiramoto@lta-med.com
1st name | |
Middle name | |
Last name | Masanari Shiramoto |
Medical Co. LTA Clinical Pharmacology Center Hakata Clinic
Clinical Pharmacology Department
Random square 5-7 F, 6-8 Tenyamachi, Hakata-ku, Fukuoka 812-0025, Japan
0922837701
masanari-shiramoto@lta-med.com
Medical Co. LTA
Clinical Pharmacology Center
Towa pharmaceutical co., LTD.
Profit organization
Towa pharmaceutical co., LTD.
NO
2014 | Year | 03 | Month | 10 | Day |
Unpublished
Completed
2014 | Year | 03 | Month | 06 | Day |
2014 | Year | 03 | Month | 10 | Day |
2014 | Year | 03 | Month | 10 | Day |
2014 | Year | 08 | Month | 19 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015610
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |