UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015281 |
|---|---|
| Receipt number | R000017717 |
| Scientific Title | A study of the effects of tube feeding on the pharmacokinetics in healthy adults |
| Date of disclosure of the study information | 2014/10/01 |
| Last modified on | 2017/10/24 07:36:58 |
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Basic information
Public title
A study of the effects of tube feeding on the pharmacokinetics in healthy adults
Acronym
A study of the effects of tube feeding on the pharmacokinetics in healthy adults
Scientific Title
A study of the effects of tube feeding on the pharmacokinetics in healthy adults
Scientific Title:Acronym
A study of the effects of tube feeding on the pharmacokinetics in healthy adults
Region
| Japan |
Condition
Condition
tube feeding
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Pharmacokinetic evaluation of the medicines in patients receiving nasogastric liquid tube feeding
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
AUC
Key secondary outcomes
Drug blood concentration
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
before meals
Interventions/Control_2
with meals
Interventions/Control_3
after meals
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)healthy volunteers
2)providing a voluntary written informed concent for the participation in this study
Key exclusion criteria
1)allergies to medications used in this study
2)food allergies
3)liver or renal dysfunction
4)digestive diseases or a past medical history of digestive diseases
5)abnormal fasting blood glucose level
6)gastrointestinal symptoms from the day before the test date
7)intake of medicines within one week before the test date
Target sample size
21
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mikiko Ueda |
Organization
Osaka University Dental Hospital
Division name
Pharmacy
Zip code
Address
1-8 Yamadaoka,Suita,osaka 565-0871
TEL
06-6879-2379
uedamkk@dent.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mikiko Ueda |
Organization
Osaka University Dental Hospital
Division name
Pharmacy
Zip code
Address
1-8 Yamadaoka,Suita,osaka 565-0871
TEL
06-6879-2379
Homepage URL
uedamkk@dent.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University Dental Hospital
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
School of Pharmaceutical Sciences Mukogawa Women's University
Graduate School of Pharmaceutical Sciences Osaka University
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
大阪大学歯学部附属病院（大阪府）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 10 | Month | 01 | 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
Completed
Date of protocol fixation
| 2014 | Year | 08 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 11 | Month | 18 | 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
| 2014 | Year | 09 | Month | 29 | Day |
Last modified on
| 2017 | Year | 10 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017717
