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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000030894 |
Receipt No. | 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 |
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 |
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Condition | ||
Condition | Healthy volunteers | |
Classification by specialty |
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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 |
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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 |
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Age-upper limit |
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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 |
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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 |
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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 | |
Institute | Fukushima Medical University |
Institute | |
Department |
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 | |
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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 |
Institutions | |
Institutions |
Other administrative information | |||||||
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 | 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 |
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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date | |||||||
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Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
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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=R000035276 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |