Unique ID issued by UMIN | UMIN000016339 |
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Receipt number | R000018920 |
Scientific Title | Effect of green tea ingestion on pharmacokinetics of fluvastatin in healthy volunteers |
Date of disclosure of the study information | 2015/02/01 |
Last modified on | 2018/02/19 09:34:14 |
Effect of green tea ingestion on pharmacokinetics of fluvastatin in healthy volunteers
Green tea-fluvastatin interaction study
Effect of green tea ingestion on pharmacokinetics of fluvastatin in healthy volunteers
Green tea-fluvastatin interaction study
Japan |
Healthy volunteers
Adult |
Others
NO
To assess the effects of brewed green tea and green tea extract on pharmacokinetics of fluvastatin
Pharmacokinetics
Exploratory
Explanatory
Not applicable
Plasma concentrations of fluvastatin
Urinary excretion of fluvastatin
Interventional
Cross-over
Randomized
Individual
Open -no one is blinded
Placebo
3
Prevention
Medicine | Food |
Subjects receive 20 mg of fluvastatin orally with 300 mL of brewed green tea after overnight fasting. Blood samples are collected before and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 24 hours after fluvastatin administration. Urine samples are obtained over 24 hours after fluvastatin administration.
Subjects receive 20 mg of fluvastatin orally with 300 mL of water and a green tea extract after overnight fasting. Blood samples are collected before and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 24 hours after fluvastatin administration. Urine samples are obtained over 24 hours after fluvastatin administration.
Subjects receive 20 mg of fluvastatin orally with 300 mL of water after overnight fasting. Blood samples are collected before and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 24 hours after fluvastatin administration. Urine samples are obtained over 24 hours after fluvastatin administration.
20 | years-old | <= |
Not applicable |
Male and Female
Healthy adults
Smoker
12
1st name | |
Middle name | |
Last name | Junko Kimura |
Fukushima Medical University, School of Medicine
Department of Pharmacology
1 Hikarigaoka, Fukushima, 9601295 Japan
024-547-1153
jkimura@fmu.ac.jp
1st name | |
Middle name | |
Last name | Shingen Misaka |
Fukushima Medical University, School of Medicine
Department of Pharmacology
1 Hikarigaoka, Fukushima, 9601295 Japan
024-547-1156
misaka@fmu.ac.jp
Fukushima Medical University
Honjo International Scholarship Foundation
Non profit foundation
Japan
NO
2015 | Year | 02 | Month | 01 | Day |
Published
https://link.springer.com/article/10.1007%2Fs00228-018-2420-x
Single concomitant administration of green tea is unlikely to affect the pharmacokinetics of fluvastatin in healthy volunteers.
Completed
2015 | Year | 01 | Month | 15 | Day |
2015 | Year | 02 | Month | 01 | Day |
2015 | Year | 01 | Month | 26 | Day |
2018 | Year | 02 | Month | 19 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018920
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