Unique ID issued by UMIN | UMIN000016460 |
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Receipt number | R000019118 |
Scientific Title | Study on BE study designing under low-gastric acid condition using gastric acid secretion inhibitor. To investigate gastric pH changes after administration of H2 blocker 10mg and 20mg. |
Date of disclosure of the study information | 2015/02/07 |
Last modified on | 2015/05/01 17:44:02 |
Study on BE study designing under low-gastric acid condition using gastric acid secretion inhibitor.
To investigate gastric pH changes after administration of H2 blocker 10mg and 20mg.
Evaluation of gastric pH changes after administration of H2 blocker
Study on BE study designing under low-gastric acid condition using gastric acid secretion inhibitor.
To investigate gastric pH changes after administration of H2 blocker 10mg and 20mg.
Evaluation of gastric pH changes after administration of H2 blocker
Japan |
Gastric Ulcer
Gastroenterology | Adult |
Others
NO
To investigate gastric pH changes after administration of famotidine (10mg and 20mg) , 2 x 2 cross over study .
PK,PD
24 hour intragastric pH and pharmacokinetics after administration of famotidine.
Interventional
Cross-over
Randomized
Open -no one is blinded
Uncontrolled
2
Treatment
Medicine |
To administer oral dose of famotidine (10mgg) and monitor gastric pH for 24 hours
To administer oral dose of famotidine (20mg) 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 Subjects who donated and/or withdrawn whole blood more than 400mL within 12 weeks, 200mL within 4 weeks, and/or blood component within 2 weeks prior to admission of period 1.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.
12
1st name | |
Middle name | |
Last name | Masanari Shiramoto |
Medical Co. LTA Hakata Clinic
Clinical Pharmacology Department
Random square 5-7 F, 6-8 Tenyamachi, Hakata-ku, Fukuoka 812-0025, Japan
092-283-7701
masanari-shiramoto@lta-med.com
1st name | |
Middle name | |
Last name | Masanari Shiramoto |
Medical Co. LTA Hakata Clinic
Clinical Pharmacology Department
Random square 5-7 F, 6-8 Tenyamachi, Hakata-ku, Fukuoka 812-0025, Japan
092-283-7701
masanari-shiramoto@lta-med.com
Medical Co. LTA Hakata Clinic
Towa pharmaceutical co., LTD.
Profit organization
NO
医療法人相生会 博多クリニック(福岡県)
2015 | Year | 02 | Month | 07 | Day |
Unpublished
Completed
2015 | Year | 02 | Month | 02 | Day |
2015 | Year | 02 | Month | 07 | Day |
2015 | Year | 07 | Month | 01 | Day |
2015 | Year | 02 | Month | 06 | Day |
2015 | Year | 05 | Month | 01 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019118
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