UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A study of the effects of tube feeding on the pharmacokinetics in healthy adults
Title of the study (Brief title)	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	Mikiko Ueda
Organization	Osaka University Dental Hospital
Division name	Pharmacy
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	Mikiko Ueda
Organization	Osaka University Dental Hospital
Division name	Pharmacy
Address	1-8 Yamadaoka,Suita,osaka 565-0871
TEL	06-6879-2379
Homepage URL
Email	uedamkk@dent.osaka-u.ac.jp

Sponsor
Institute	Osaka University Dental Hospital
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 08 Month 27 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000017717