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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000026208
Receipt No. R000030095
Scientific Title Evaluation of disintegration time and palatability of mitiglinide-voglibose combined orally disintegrating tablet.
Date of disclosure of the study information 2017/02/20
Last modified on 2017/06/30

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Basic information
Public title Evaluation of disintegration time and palatability of mitiglinide-voglibose combined orally disintegrating tablet.
Acronym Disintegration time and palatability of mitiglinide-voglibose combined orally disintegrating tablet.
Scientific Title Evaluation of disintegration time and palatability of mitiglinide-voglibose combined orally disintegrating tablet.
Scientific Title:Acronym Disintegration time and palatability of mitiglinide-voglibose combined orally disintegrating tablet.
Region
Japan

Condition
Condition Healthy adults
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to compare the palatability and disintegration time between an intake of mitiglinide-voglibose combined orally disintegrating tablet (ODT) and a concomitant intake of mitiglinide ODT and voglibose ODT.
Basic objectives2 Others
Basic objectives -Others Evaluation of charactoristics of pharmacutical formulations
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes palatability
Key secondary outcomes disintegrating time

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 mitiglinide-voglibose combined orally disintegrating tablet
Interventions/Control_2 mitiglinide orally disintegrating tablet and voglibose orally disintegrating tablet
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

Not applicable
Gender Male and Female
Key inclusion criteria Healthy adult(male and female)
Key exclusion criteria 1.clearly taste disorder
2.allegy for drugs
3.pregnant and/or lactating women
4.other who was decided as inadequate by doctor
Target sample size 25

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroshi Watanabe
Organization Hamamatsu University School of Medicine

Division name Department of Clinical Pharmacology and Therapeutics
Zip code
Address 1-20-1,Handayama,Higashi-ku,Hamamatsu
TEL 053-435-2385
Email hwat@hama-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Akio Hakamata
Organization Hamamatsu University School of Medicine
Division name Department of Clinical Pharmacology and Therapeutics
Zip code
Address 1-20-1,Handayama,Higashi-ku,Hamamatsu
TEL 053-435-2385
Homepage URL
Email hakamata@hama-med.ac.jp

Sponsor
Institute Hamamatsu University School of Medicine
Institute
Department

Funding Source
Organization Department of Pharmacy Practice and Science, School of Pharmaceutical Sciences University of Shizuoka
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
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

Other administrative information
Date of disclosure of the study information
2017 Year 02 Month 20 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
2017 Year 02 Month 20 Day
Date of IRB
Anticipated trial start date
2017 Year 02 Month 20 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
2017 Year 02 Month 18 Day
Last modified on
2017 Year 06 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030095

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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