UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030894 |
|---|---|
| Receipt number | R000035276 |
| Scientific Title | Influence of green tea ingestion on the pharmacokinetics of lisinopril in healthy volunteers |
| Date of disclosure of the study information | 2018/01/20 |
| Last modified on | 2020/10/19 16:53:18 |
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Basic information
Public title
Influence of green tea ingestion on the pharmacokinetics of lisinopril in healthy volunteers
Acronym
Green tea-lisinopril study
Scientific Title
Influence of green tea ingestion on the pharmacokinetics of lisinopril in healthy volunteers
Scientific Title:Acronym
Green tea-lisinopril study
Region
| Japan |
Condition
Condition
Healthy volunteers
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Difference in pharmacokinetic parameters of lisinopril by ingestion of green tea catechins
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Area under the plasma concentration-time curve (AUC) of lisinopril
Key secondary outcomes
Urinary excretion of lisinopril
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
NO
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine | Food |
Interventions/Control_1
Subjects receive an oral dose of lisinopril (Zestril 10mg tablet, Astrazeneca) with 200 ml of water after overnight fasting. Blood sampling and measurements of pulse rate and blood pressure are performed before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours after lininopril administration. Urine collection is performed over 24 hours after the administration. Subjects have a snack and a lunch at 1 and 4 hours, respectively, after the administration.
Interventions/Control_2
Subjects receive an oral dose of lisinopril (Zestril 10mg tablet, Astrazeneca) with 200 ml of water dissolving a green tea extract (epigallocatechin gallate dose: 300 mg) after overnight fasting. Blood sampling and measurements of pulse rate and blood pressure are performed before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours after lininopril administration. Urine collection is performed over 24 hours after the administration. Subjects have a snack and a lunch at 1 and 4 hours, respectively, after the administration.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
To be healthy without receiving medicines regularly
Key exclusion criteria
Smoker
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yayoi Kameoka |
Organization
Fukushima Medical University
Division name
Center for Medical Education and Career Development
Zip code
Address
1 Hikarigaoka, Fukushima 9601295, Japan
TEL
024-547-1156
yayois@fmu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shingen Misaka |
Organization
Fukushima Medical University
Division name
Department of Pharmacology
Zip code
Address
1 Hikarigaoka, Fukushima 9601295, Japan
TEL
024-547-1156
Homepage URL
misaka@fmu.ac.jp
Sponsor or person
Institute
Fukushima Medical University
Institute
Department
Personal name
Funding Source
Organization
Nakatomi Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2018 | Year | 01 | Month | 20 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.1111/cts.12905
Number of participants that the trial has enrolled
10
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
| 2016 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 01 | Month | 15 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 01 | Month | 19 | Day |
Last modified on
| 2020 | Year | 10 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035276
