UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002860 |
|---|---|
| Receipt number | R000003490 |
| Scientific Title | Clinical study with healthy volunteer to measure the volume of gastric fluid after oral drug administration |
| Date of disclosure of the study information | 2009/12/16 |
| Last modified on | 2009/12/08 14:11:05 |
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Basic information
Public title
Clinical study with healthy volunteer to measure the volume of gastric fluid after oral drug administration
Acronym
Clinical study to measure the volume of gastric fluid after oral drug administration
Scientific Title
Clinical study with healthy volunteer to measure the volume of gastric fluid after oral drug administration
Scientific Title:Acronym
Clinical study to measure the volume of gastric fluid after oral drug administration
Region
| Japan |
Condition
Condition
digestive disorder
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The main purpose of this study is to calculate the volume of gastric fluid by measuring the drug concentration in the stomach after oral administration of non-absorbable drug. Also, by co-administration of highly absorbable drugs, drug absorption from stomach is analyzed quantitatively.
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Time-course of drug concentration in the gastric fluid (for 3 hours after oral administration)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Number of subjects : 8
Period of study: 2 days
1) Volunteers are fasted overnight.
2) Volunteers are administered water containing atenolol and salicylic acid then gastric fluid is sampled periodically.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 40 | years-old | > |
Gender
Male
Key inclusion criteria
1) Men, Japanese,
If students, this volunteer shop does not affect the required course in their University.
2) BMI is 18.5>= and <25.0.
Key exclusion criteria
1)Who having (or had) a medical history of circulatory system disease, hepatic disease, renal disease, digestive system disease, hematological disorder.
2)Who taking a medicine that night affect the study result.
3)Who judged as inappropriate to this study by the primary doctor of this study from diagnosis, vital signs, inductive electrocardiograph, hematological assessment, blood biochemical test, urinary test, immunological test.
4)Who took a medicine within 7 days before the study
5)Who participated in the clinical trail and took a test medicine within 3 months before the study.
6)Who having (or had) an allergic constitution to medicine/food
7)Who having (or had) a dependency to drug or alcohol
8)Who judged as inappropriate to this study by the primary doctor due to any other reasons
Target sample size
8
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shinji Yamashita |
Organization
Setsunan University
Division name
Faculty of Pharmaceutical Sciences
Zip code
Address
45-1, Nagaotoge-cho, Hirakata, Osaka, Japan
TEL
072-866-3125
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shinji Yamashita |
Organization
Setsunan University
Division name
Faculty of Pharmaceutical Sciences
Zip code
Address
TEL
Homepage URL
shinji@pharm.setsunan.ac.jp
Sponsor or person
Institute
Faculty of Pharmaceutical Sciences, Setsunan University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Towa Pharmaceutical Co. Ltd.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
医療法人相生会 博多クリニック（福岡県）
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 12 | Month | 16 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2009 | Year | 10 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 11 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 12 | Month | 08 | Day |
Last modified on
| 2009 | Year | 12 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003490
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
