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

Email

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


Email

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&#39;s University

Graduate School of Pharmaceutical Sciences Osaka University

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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name