UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000002860
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email

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
Email shinji@pharm.setsunan.ac.jp

Sponsor
Institute Faculty of Pharmaceutical Sciences, Setsunan University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003490

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.