Unique ID issued by UMIN | UMIN000019761 |
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Receipt number | R000022822 |
Scientific Title | Dose-dependent effects of green tea catechin on pharmacokinetics of nadolol in healthy volunteers |
Date of disclosure of the study information | 2015/12/01 |
Last modified on | 2018/03/01 09:26:13 |
Dose-dependent effects of green tea catechin on pharmacokinetics of nadolol in healthy volunteers
GT-nadolol interaction study 3
Dose-dependent effects of green tea catechin on pharmacokinetics of nadolol in healthy volunteers
GT-nadolol interaction study 3
Japan |
Healthy volunteers
Adult |
Others
NO
To investigate dose-dependent effects of green tea catechin on pharmacokinetics of nadolol in healthy adult volunteers.
Pharmacokinetics
Exploratory
Explanatory
Not applicable
Blood samples are collected before and at 0.5, 1, 2, 3, 4, 6, 8, 24,and 48 hours after nadolol administration. Urine samples are obtained over 48 hours after nadolol administration. Blood pressure and pulse rate are monitored before and at 0.5, 1, 2, 3, 4, 6, 8, 24, and 48 hours after nadolol adoministration.
Plasma concentrations of nadolol
Urinary excretions of nadolol
Blood pressure
Pulse rate
Interventional
Cross-over
Randomized
Individual
Open -no one is blinded
Placebo
6
Prevention
Medicine | Food |
Subjects in this group receive 30 mg of nadolol orally with 300 mL of water after overnight fasting. In the second phase, subjects receive 30 mg of nadolol orally with 50 mg of green tea extract dissolved in 300 mL of water after overnight fasting. In the third phase, subjects receive 30 mg of nadolol orally with 150 mg of green tea extract dissolved in 300 mL of water after overnight fasting. The washout period between phases is at least one week.
Subjects in this group receive 30 mg of nadolol orally with 300 mL of water after overnight fasting. In the second phase, subjects receive 30 mg of nadolol orally with 150 mg of green tea extract dissolved in 300 mL of water after overnight fasting. In the third phase, subjects receive 30 mg of nadolol orally with 50 mg of green tea extract dissolved in 300 mL of water after overnight fasting. The washout period between phases is at least one week.
Subjects in this group receive 30 mg of nadolol orally with 50 mg of green tea extract dissolved in 300 mL of water after overnight fasting. In the second phase, subjects receive 30 mg of nadolol orally with 300 mL of water after overnight fasting. In the third phase, subjects receive 30 mg of nadolol orally with 150 mg of green tea extract dissolved in 300 mL of water after overnight fasting. The washout period between phases is at least one week.
Subjects in this group receive 30 mg of nadolol orally with 50 mg of green tea extract dissolved in 300 mL of water after overnight fasting. In the second phase, subjects receive 30 mg of nadolol orally with 150 mg of green tea extract dissolved in 300 mL of water after overnight fasting. In the third phase, subjects receive 30 mg of nadolol orally with 300 mL of water after overnight fasting. The washout period between phases is at least one week.
Subjects in this group receive 30 mg of nadolol orally with 150 mg of green tea extract dissolved in 300 mL of water after overnight fasting. In the second phase, subjects receive 30 mg of nadolol orally with 300 mL of water after overnight fasting. In the third phase, subjects receive 30 mg of nadolol orally with 50 mg of green tea extract dissolved in 300 mL of water after overnight fasting. The washout period between phases is at least one week.
Subjects in this group receive 30 mg of nadolol orally with 150 mg of green tea extract dissolved in 300 mL of water after overnight fasting. In the second phase, subjects receive 30 mg of nadolol orally with 50 mg of green tea extract dissolved in 300 mL of water after overnight fasting. In the third phase, subjects receive 30 mg of nadolol orally with 300 mL of water after overnight fasting. The washout period between phases is at least one week.
20 | years-old | <= |
Not applicable |
Male and Female
Healthy volunteers
Smoker
12
1st name | |
Middle name | |
Last name | Junko Kimura |
Fukushima Medical University, School of Medicine
Department of Phamacology
1 Hikarigaoka, Fukushima, 9601295 Japan
024-547-1156
jkimura@fmu.ac.jp
1st name | |
Middle name | |
Last name | Osamu Abe |
Fukushima Medical University, School of Medicine
Department of Phamacology
1 Hikarigaoka, Fukushima, 9601295 Japan
024-547-1156
osamu-a@fmu.ac.jp
Fukushima Medical University
Honjo International Scholarship Foundation
Non profit foundation
Japan
NO
2015 | Year | 12 | Month | 01 | Day |
Published
https://www.ncbi.nlm.nih.gov/pubmed/29480324
Completed
2015 | Year | 10 | Month | 22 | Day |
2015 | Year | 12 | Month | 01 | Day |
Intervention No.11 to No.24 can be predicted by intervention from No.1 to No.10
2015 | Year | 11 | Month | 12 | Day |
2018 | Year | 03 | Month | 01 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022822
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