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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | C000000038 |
Receipt No. | 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 |
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. | |
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Condition | ||
Condition | healthy male volunteers | |
Classification by specialty |
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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 |
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Interventions/Control_1 | Tien-cha ingection | |
Interventions/Control_2 | water ingestion | |
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Interventions/Control_10 |
Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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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 |
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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 |
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Target sample size | 8 |
Research contact person | |||||||
Name of lead principal investigator |
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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 | ||||||
nuchida@med.showa-u.ac.jp |
Public contact | |||||||
Name of contact person |
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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 | |||||||
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) | |
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Secondary IDs | |
Secondary IDs | NO |
Study ID_1 | |
Org. issuing International ID_1 | |
Study ID_2 | |
Org. issuing International ID_2 | |
IND to MHLW |
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Date of disclosure of the study information |
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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 |
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Recruitment status | Completed | ||||||
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000078 |
Research Plan | |
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Research case data specifications | |
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Research case data | |
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