Unique ID issued by UMIN | UMIN000008664 |
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Receipt number | R000010185 |
Scientific Title | Study on BE study designing under low-gastric acid condition using gastric acid secretion inhibitor. -Evaluation of gastric pH changes after administration of PPI for subjects identified as CYP2C19 homozygous extensive metabolizer - |
Date of disclosure of the study information | 2012/08/18 |
Last modified on | 2012/12/13 15:14:25 |
Study on BE study designing under low-gastric acid condition using gastric acid secretion inhibitor. -Evaluation of gastric pH changes after administration of PPI for subjects identified as CYP2C19 homozygous extensive metabolizer -
Evaluation of gastric pH changes after administration of PPI.
Study on BE study designing under low-gastric acid condition using gastric acid secretion inhibitor. -Evaluation of gastric pH changes after administration of PPI for subjects identified as CYP2C19 homozygous extensive metabolizer -
Evaluation of gastric pH changes after administration of PPI.
Japan |
Healthy male
Adult |
Others
YES
To see the changes in 24 hour gastric pH after oral administration of gastric secretion inhibiter, 2 x 2 cross over study, under fasted and fed condition.
PK,PD
24 hour intragastric pH and pharmacokinetics after administration of sodium rabeprazole
Interventional
Cross-over
Randomized
Open -no one is blinded
Uncontrolled
2
Treatment
Medicine |
To administer oral dose of sodium rabeprazole
To 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 identified as CYP2C19 homozygous extensive metabolizer.
4, Subjects with BMI <=18.5 and >25.0 at the time of screening.
5, 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 administration 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 Subjects who donated and/or withdrawn whole blood more than 400mL within 12 weeks, 200mL within 4 weeks, and/or blood component within 2 weeks prior to administration of period 1.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.
6
1st name | |
Middle name | |
Last name | Masanari Shiramoto |
Medical Co. LTA
Clinical Pharmacology Center
Hakata Clinic
Clinical Pharmacology Department
Random square, 6-8 Tenyamachi, Hakata-ku, Fukuoka Japan
1st name | |
Middle name | |
Last name |
Medical Co. LTA Clinical Pharmacology Center Hakata Clinic
Clinical Pharmacology Department
092-283-7701
Medical Co. LTA
Clinical Pharmacology Center
Towa pharmaceutical co., LTD.
Profit organization
NO
2012 | Year | 08 | Month | 18 | Day |
Unpublished
Completed
2012 | Year | 08 | Month | 01 | Day |
2012 | Year | 08 | Month | 17 | Day |
2012 | Year | 09 | Month | 01 | Day |
2012 | Year | 08 | Month | 10 | Day |
2012 | Year | 12 | Month | 13 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010185
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