UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004997 |
|---|---|
| Receipt number | R000005939 |
| Scientific Title | Pharmacokinetics of rosmarinic acid in healthy volunteers |
| Date of disclosure of the study information | 2011/03/01 |
| Last modified on | 2011/08/04 17:16:27 |
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Basic information
Public title
Pharmacokinetics of rosmarinic acid in healthy volunteers
Acronym
Pharmacokinetics of rosmarinic acid in healthy volunteers
Scientific Title
Pharmacokinetics of rosmarinic acid in healthy volunteers
Scientific Title:Acronym
Pharmacokinetics of rosmarinic acid in healthy volunteers
Region
| Japan |
Condition
Condition
healthy volunteers
Classification by specialty
| Neurology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of the study is to evaluate pharmacokinetics of rosmarinic acid (Melissa officinalis extract) in normal subjects.
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase I
Assessment
Primary outcomes
To evaluiate the pharmacokinetic variables including Cmax, T1/2, and AUC after rosmarinic acid (Melissa officinalis extract) intake, at fasting state and postprandial period.
Key secondary outcomes
To evaluate the tolerability and safety including incidence of adverse events, blood tests, vital signs and the incidence rates of completion of rosmarinic acid (Melissa officinalis extract).
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
6
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
1. placebo at fasting
2. washout ten days
3. rosmarinic acid 250mg at fasting
4. wash out ten days
5. rosmarinic acid 100mg at fasting
Interventions/Control_2
1. rosmarinic acid 250mg at fasting
2. washout ten days
3. placebo at fasting
4. wash out ten days
5. rosmarinic acid 500mg at fasting
Interventions/Control_3
1. rosmarinic acid 100mg at fasting
2. washout ten days
3. rosmarinic acid 500mg at fasting
4. wash out ten days
5. placebo at fasting
Interventions/Control_4
1. placebo after meals
2. washout ten days
3. rosmarinic acid 250mg after meals
4. wash out ten days
5. rosmarinic acid 100mg after meals
Interventions/Control_5
1. rosmarinic acid 250mg after meals
2. washout ten days
3. placebo after meals
4. wash out ten days
5. rosmarinic acid 500mg after meals
Interventions/Control_6
1. rosmarinic acid 100mg after meals
2. washout ten days
3. rosmarinic acid 500mg after meals
4. wash out ten days
5. placebo after meals
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Healthy volunteer who provided written informed consent.
Key exclusion criteria
1. Consumption of the rosmarinic acid-containing supplement within 15 days before the first rosmarinic acid administration.
2. The dementia including Alzheimer disease.
3. The liver and renal severe dysfunction.
4. The diseases of any malignancy to need continuous medical treatment.
5. Chronic alcoholism, or substance abuse
6. Subjects with a history of severe allergies of polyphenols.
7. Subjects with a history of severe allergies of any drug and food.
8. Participation in any other clinical trial
9. Pregnancy or lactation in women.
10. Any others judged by the investigators to be inappropriate for the subject of this study
Target sample size
18
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masahito Yamada |
Organization
Kanazawa University Graduate School of Medical science
Division name
Department of Neurology and Neurobiology of Aging
Zip code
Address
13-1 Takara-machi, Kanazawa, Ishikawa, 920-8641, Japan
TEL
076-265-2000
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kenjiro Ono, Moeko Shinohara |
Organization
Kanazawa University Graduate School of Medical science
Division name
Department of Neurology and Neurobiology of Aging
Zip code
Address
13-1 Takara-machi, Kanazawa, Ishikawa, 920-8641, Japan
TEL
076-265-2292
Homepage URL
http://web.kanazawa-u.ac.jp/~med19/
Sponsor or person
Institute
Kanazawa University Graduate School of Medical science
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
None
Other related organizations
Co-sponsor
Takasaki University of Health and welfare
Tokyo University Graduate School of Agricultural and Life Sciences
Name of secondary funder(s)
Maruzen Pharmacenticals co., LTd
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
金沢大学病院（石川県）
kanazawa University Hospital (Ishikawa)
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 03 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
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
| 2011 | Year | 02 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 02 | Month | 01 | Day |
Last modified on
| 2011 | Year | 08 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005939
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
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