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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000026036
Receipt No. 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

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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
Email 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
Email s.tsuji@ttc-tokyo.co.jp

Sponsor
Institute TTC Co.,Ltd.
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029928

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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