UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026036 |
|---|---|
| Receipt number | R000029928 |
| Scientific Title | Evaluation of capsules solubility (two groups) |
| Date of disclosure of the study information | 2017/02/07 |
| Last modified on | 2018/09/05 11:40:07 |
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Basic information
Public title
Evaluation of capsules solubility (two groups)
Acronym
Evaluation of capsules solubility (two groups)
Scientific Title
Evaluation of capsules solubility (two groups)
Scientific Title:Acronym
Evaluation of capsules solubility (two groups)
Region
| Japan | Asia(except Japan) |
Condition
Condition
Healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Comparison of solubility of new film capsule and conventional film capsule in sequential X-ray photography
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Disintegration and disintegration time of capsule in X-ray contrast
Key secondary outcomes
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
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Intake of new film capsule (single ingestion)
Interventions/Control_2
Intake of conventional film capsule (single ingestion)
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
| 64 | years-old | >= |
Gender
Male
Key inclusion criteria
Healthy Males from 20 to 64 years of age
Key exclusion criteria
(1) Subjects having a disease requiring treatment or a history of serious diseases, diabetes, hepatopathy, renal or heart disease
(2) Subjects having possibilities for emerging allergy related to the study
(3) Subjects having a disease requiring treatment or a history of serious diseases for which medication was required
(4) Subjects who are judged as unsuitable for the study based on the results of clinical and physical examination on preliminary examination
(5) Subjects who have participated in other clinical study within the last one month prior to the current study or are planned to participate in other clinical study after informed consent for the current study
(6) Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire
(7) Subjects judged as unsuitable for the study by the investigator for other reasons
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takanori Kobayashi |
Organization
Sunsho Pharmaceutical Co., Ltd
Division name
Research and Development Division
Zip code
Address
533-2, Ooiwa, Fujinomiya-shi, Shizuoka-ken
TEL
0544-68-4750
kobayashi@sunsho.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shinsuke Tsuji |
Organization
TTC Co.,Ltd.
Division name
Clinical Research Planning Department
Zip code
Address
Seibu Shinkin Bank Ebisu Bldg.,1-20-2, Ebisunishi, Shibuya-ku, Tokyo
TEL
03-5459-5329
Homepage URL
s.tsuji@ttc-tokyo.co.jp
Sponsor or person
Institute
TTC Co.,Ltd.
Institute
Department
Personal name
Funding Source
Organization
Sunsho Pharmaceutical Co., Ltd
Organization
Division
Category of Funding Organization
Profit organization
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 | 07 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Conventional film capsules collapsed in about 20 to 40 minutes after reaching the stomach.
The new film capsules did not dissolve in the stomach and collapsed in about 40 to 80 minutes after reaching the small intestine.
From the above results, it was demonstrated that the new film capsule functions as an enteric capsule even in the human body.
In addition, adverse events did not occur after ingestion for conventional film capsules and new film capsules, and safety problems were not observed.
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 | 01 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 02 | Month | 08 | 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 | 07 | Day |
Last modified on
| 2018 | Year | 09 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029928
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
