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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004997
Receipt No. 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

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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
Email

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/
Email

Sponsor
Institute Kanazawa University Graduate School of Medical science
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005939

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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