UMIN-CTR Clinical Trial

Unique ID issued by UMIN	C000000038
Receipt number	R000000078
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 -
Date of disclosure of the study information	2006/03/10
Last modified on	2016/04/09 12:00:57

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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

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

healthy male volunteers

Classification by specialty

Not applicable

Classification by malignancy

Others

Genomic information

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

Dynamic allocation

Institution consideration

Institution is not considered as adjustment factor.

Blocking

Concealment

No need to know

Intervention

No. of arms

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

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 or person

Institute

Second Department of Pharmacology, Showa University, School of Medicine

Institute

Department

Personal name

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

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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

Value
https://center6.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

1st name
Middle name
Last name	Naoki UCHIDA, MD, PhD