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UMIN-CTR Clinical Trial |
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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 |
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 |
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Condition | ||
Condition | Healthy adult | |
Classification by specialty |
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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 |
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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 |
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Age-upper limit |
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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 |
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Target sample size | 12 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
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 | |
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 |
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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 |
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Date of IRB | |||||||
Anticipated trial start date |
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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 |
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Last modified on |
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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 |