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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000034092 |
Receipt No. | R000038866 |
Scientific Title | Pharmacokinetics study of food ingredient. (SBF-2018-03-THIY) |
Date of disclosure of the study information | 2018/09/12 |
Last modified on | 2019/05/22 |
Basic information | ||
Public title | Pharmacokinetics study of food ingredient. (SBF-2018-03-THIY) | |
Acronym | Pharmacokinetics study of food ingredient. | |
Scientific Title | Pharmacokinetics study of food ingredient. (SBF-2018-03-THIY) | |
Scientific Title:Acronym | Pharmacokinetics study of food ingredient. | |
Region |
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Condition | ||
Condition | Not applicable | |
Classification by specialty |
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Classification by malignancy | Others | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | To evaluate the pharmacokinetics of food ingredient. |
Basic objectives2 | PK,PD |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | t1/2
Cmax Tmax |
Key secondary outcomes |
Base | |
Study type | Interventional |
Study design | |
Basic design | Single arm |
Randomization | Non-randomized |
Randomization unit | |
Blinding | Open -no one is blinded |
Control | Uncontrolled |
Stratification | |
Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment |
Intervention | ||
No. of arms | 1 | |
Purpose of intervention | Prevention | |
Type of intervention |
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Interventions/Control_1 | Single ingestion of test food | |
Interventions/Control_2 | ||
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 and Female | |||
Key inclusion criteria | (1)Healthy male and female whose age are 40 <= years old <70.
(2)Subjects who are able to submit the written informed consents. |
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Key exclusion criteria | (1)Subjects who are with treatment.
(2)Subjects who are with history of gastrointestinal surgery. (3)Subjects who are attending other studies or attended other studies within the past 4 weeks. (4)Subjects who are; a)With present heart disorder, liver disorder, or kidney disorder, b)With history of cardiac disorder, c)With diabetes mellitus, or d)With allergy to the study foods. (5)Subjects who are not negative for syphilis, HBs antigen, HCV antibody, HIV antigen/antibody or HTLV-1 antibody test. (6)Subjects who are deemed to be unsuitable by the investigator. |
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Target sample size | 12 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Suntory Beverage & Food Limited | ||||||
Division name | Development and Design Department | ||||||
Zip code | |||||||
Address | 13-2 Imaikamicho, Nakahara, Kawasaki, Kanagawa, 211-0067 Japan | ||||||
TEL | 050-3182-6114 | ||||||
Takanori_Teramoto@suntory.co.jp |
Public contact | |||||||
Name of contact person |
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Organization | Suntory Beverage & Food Limited | ||||||
Division name | Development and Design Department | ||||||
Zip code | |||||||
Address | 13-2 Imaikamicho, Nakahara, Kawasaki, Kanagawa, 211-0067 Japan | ||||||
TEL | 050-3182-0666 | ||||||
Homepage URL | |||||||
Noriyuki_Kanzaki@suntory.co.jp |
Sponsor | |
Institute | Suntory Beverage & Food Limited |
Institute | |
Department |
Funding Source | |
Organization | Suntory Beverage & Food Limited |
Organization | |
Division | |
Category of Funding Organization | Self funding |
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 | 12 |
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 |
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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=R000038866 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |