UMIN-CTR Clinical Trial

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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