UMIN-CTR Clinical Trial

Basic information
Public title	The Effects of multiple ingestion of Tien-cha (herb tea: Rubus suavissimus) on pharmacokinetics after single oral administration of 10 mg simvastatin, HMG-CoA reductase inhibiter, in healthy young male volunteers.- Open crossover design compared to water ingestion group -
Acronym	The effects of multiple ingestion of Tien-cha (herb tea: Rubus suavissimus) on pharmacokinetics after single oral administration of 10 mg simvastatin.
Scientific Title	The Effects of multiple ingestion of Tien-cha (herb tea: Rubus suavissimus) on pharmacokinetics after single oral administration of 10 mg simvastatin, HMG-CoA reductase inhibiter, in healthy young male volunteers.- Open crossover design compared to water ingestion group -
Scientific Title:Acronym	The effects of multiple ingestion of Tien-cha (herb tea: Rubus suavissimus) on pharmacokinetics after single oral administration of 10 mg simvastatin.
Region	Japan

Condition
Condition	healthy male volunteers
Classification by specialty	Not applicable
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study was to investigate the effects of multiple ingestion of Tien-cha (Rubus suavissimus) on pharmacokinetics after single oral administration of 10 mg of simvastatin compared to water ingestion. The study was conducted by open 2 period crossover design with 2 groups, previous water ingestion and Tien-cha ingestion group. Subjects were randomly allocated to these two groups. The primary and secondary endpoints of the study were PK parameters of simvastatin and safety assessments.
Basic objectives2	Pharmacokinetics
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	AUC, Cmax of plasma simvastatin
Key secondary outcomes	tmax, t1/2, CL/F of plasma simvastatin and safety assessment

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Placebo
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking
Concealment	No need to know

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Tien-cha ingection
Interventions/Control_2	water 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	20 years-old <=
Age-upper limit	40 years-old >
Gender	Male
Key inclusion criteria	1.written informed consent 2.age 20<= <40 (on screening day) 3.male 4.BMI(Body Mass Index):18.5-25.0
Key exclusion criteria	1.Any present status or medical history of circulatory system, respiratory system, digestive system, hemotogeneous system and renal function or hepatic function disorder 2.Any drug allergy history 3.Drug abuse, alcoholic abuse 4.Smoking habit 5.Participation in any clinical trial within 4 months 6.Collected blood more than 200mL within 3 months 7.Tien-cha ingestion in the 2 weeks prior to study drug administration 8.Grape fruits juice ingestion in the 2 weeks prior to study drug administration 9.Any use of St Johns wart in the 2 weeks prior to study drug administration 10.Any use of drugs including OTCs in the 2 weeks prior to study drug administration 11.Any clinically significant abnormalities on the results of screening examination which was conducted in 4 the weeks prior to study drug administration 12.Any clinically significant abnormalities on the examination which was conducted before study drug administration 13.Any use of prescribed medicines 14.Any presence or family history of inherited muscle disease (such as muscular dystrophy) 15.Subjects who, in the opinion of the investigator, are not likely to participate in the study for any reason
Target sample size	8

Research contact person
Name of lead principal investigator	1st name Middle name Last name Naoki UCHIDA, MD, PhD
Organization	Showa University, School of Medicine
Division name	Second Department of Pharmacology
Zip code
Address	Hatanodai Shinagawa-ku Tokyo 142-8555 Japan
TEL	03-3784-8128
Email	nuchida@med.showa-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Naoki UCHIDA, MD, PhD
Organization	Showa University, School of Medicine
Division name	Second Department of Pharmacology
Zip code
Address	Hatanodai Shinagawa-ku Tokyo 142-8555
TEL	03-3784-8128
Homepage URL
Email	nuchida@med.showa-u.ac.jp

Sponsor
Institute	Second Department of Pharmacology, Showa University, School of Medicine
Institute
Department

Funding Source
Organization	Japan research foundation for clinical pharmacology
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	Medical Corporation Keiyu-Kai Group, Obara Hospital
Name of secondary funder(s)	none

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

Other administrative information
Date of disclosure of the study information	2006 Year 03 Month 10 Day

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	No adverse event was reported during the study. There were large inter-individual differences in pharmacokinetic parameter of plasma simvastatin after oral administration. The geometric means (and 95% confidence intervals) of Cmax and AUC (Tein-cha - water) were 1.29 ng/mL (0.94, 1.65), 0.94 ng*hr/mL (0.49, 1.39), respectively. And the arithmetic means (and 95% confidence intervals) of tmax, t1/2 and CL/F (Tein-cha - water) were 0.56 hr (-1.30, 0.17), 0.83 hr (-3.10, 1.43), 37.5 mL/hr (-416.40, 491.38), respectively. There were no significant differences in pharmacokinetic parameters of plasma simvastatin in both Tein-cha and water ingestion group.Jpn. J Clin. Pharmacol. Ther., 36(Suppl): S275, 2005
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	2005 Year 01 Month 26 Day
Date of IRB
Anticipated trial start date	2005 Year 02 Month 01 Day
Last follow-up date	2005 Year 03 Month 01 Day
Date of closure to data entry	2005 Year 08 Month 01 Day
Date trial data considered complete	2005 Year 09 Month 01 Day
Date analysis concluded	2005 Year 11 Month 01 Day

Other
Other related information

Management information
Registered date	2005 Year 08 Month 05 Day
Last modified on	2016 Year 04 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000078

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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