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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000028112
Receipt No. R000029950
Scientific Title Effects of danshen on the pharmacokinetics of rosuvastatin
Date of disclosure of the study information 2017/07/06
Last modified on 2017/12/23

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Basic information
Public title Effects of danshen on the pharmacokinetics of rosuvastatin
Acronym Danshen effects on Pharmacokinetics of rosuvastatin
Scientific Title Effects of danshen on the pharmacokinetics of rosuvastatin
Scientific Title:Acronym Danshen effects on Pharmacokinetics of rosuvastatin
Region
Japan

Condition
Condition healthy volunteer
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Evaluate the drug-interaction between Kampo medicine and western drug.
Basic objectives2 Pharmacokinetics
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes change in pharmacokinetics
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 sigle oral dose of rosuvastatin 5 mg with placebo
Interventions/Control_2 single oral dose of rosuvastatin 5mg with danshen formula 2.5g
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
50 years-old >
Gender Male
Key inclusion criteria healthy male volunteer
Key exclusion criteria volunteer with history of psychiatric disorder and alcohol poisoning, cigarette smoker
Target sample size 6

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Junichi Hasegawa
Organization Tottori University Faculty of Medicine
Division name Pharmacotherpeutics
Zip code
Address 86 Nishicho, Yonago 683-8503, Japan
TEL 0859-38-6171
Email hasegawa@med.tottori-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Junichi Hasegawa
Organization Tottori University Faculty of Medicine
Division name Pharmacotherapeutics
Zip code
Address 86 Nishicho , Yonago
TEL 0859-38-6171
Homepage URL
Email hasegawa@med.tottori-u.ac.jp

Sponsor
Institute Tottori University
Institute
Department

Funding Source
Organization Tottori University Hospital
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

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 鳥取大学医学部附属病院

Other administrative information
Date of disclosure of the study information
2017 Year 07 Month 06 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
Danshen reduced the AUC of rosuvastatin.
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 04 Month 13 Day
Date of IRB
Anticipated trial start date
2017 Year 07 Month 12 Day
Last follow-up date
2017 Year 10 Month 05 Day
Date of closure to data entry
2017 Year 11 Month 22 Day
Date trial data considered complete
2017 Year 11 Month 22 Day
Date analysis concluded
2017 Year 12 Month 11 Day

Other
Other related information

Management information
Registered date
2017 Year 07 Month 06 Day
Last modified on
2017 Year 12 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029950

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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