UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026208 |
|---|---|
| Receipt number | 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 15:56:34 |
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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
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
hakamata@hama-med.ac.jp
Sponsor or person
Institute
Hamamatsu University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030095
