Unique ID issued by UMIN | UMIN000032828 |
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Receipt number | R000037438 |
Scientific Title | Influence of green tea on pharmacokinetics of fexofenadine in healthy volunteers |
Date of disclosure of the study information | 2018/06/01 |
Last modified on | 2022/06/30 17:02:32 |
Influence of green tea on pharmacokinetics of fexofenadine in healthy volunteers
Green tea - fexofenadine interaction study
Influence of green tea on pharmacokinetics of fexofenadine in healthy volunteers
Green tea - fexofenadine interaction study
Japan |
Healthy adults
Adult |
Others
YES
Difference in pharmacokinetic parameters of fexofenadine by green tea catechins
Bio-equivalence
Exploratory
Explanatory
Not applicable
Area under the plasma concentration-time curve (AUC) of fexofenadine
Urinary excretion of fexofenadine
Interventional
Cross-over
Randomized
Individual
Open -no one is blinded
Placebo
NO
NO
Institution is not considered as adjustment factor.
NO
2
Prevention
Medicine | Food |
Volunteers receive 60 mg of fexofenadine (Dellegra combination tablet, Sanofi) with 200 mL of water after overnight fasting. Blood sample is collected at 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours after fexofenadine 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.
Volunteers receive 60 mg of fexofenadine (Dellegra combination tablet, Sanofi) with 200 mL of water dissolving a green tea extract (epigallocatechin gallate dose: 300 mg) after overnight fasting. Blood sample is collected at 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 24 hours after fexofenadine 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.
20 | years-old | <= |
Not applicable |
Male and Female
Eligibility for participation in the trial is assessed by the following clinical laboratory data: total protein, 6.7-8.3 g/dL; total birilubin, 0.3-1.2 mg/dL; BUN: 8.0-22.0 mg/dL; creatinine, 0.61-1.04 mg/dL; AST, 10-40 U/L; ALT, 5-40 U/L; LDH, 115-245 U/L; WBC, 3900-9800 /uL; RBC, 427-570 x10000/uL; hemoglobin, 13.5-17.6 g/dL.
Smoker
12
1st name | |
Middle name | |
Last name | Kenju Shimomura |
Fukushima Medical University
Department of bioregulation and pharmacological medicine
1 Hikarigaoka, Fukushima 9601295, Japan
024-547-1156
shimomur@fmu.ac.jp
1st name | |
Middle name | |
Last name | Shingen Misaka |
Fukushima Medical University
Department of bioregulation and pharmacological medicine
1 Hikarigaoka, Fukushima 9601295, Japan
024-547-1156
misaka@fmu.ac.jp
Fukushima Medical University
Japan Society for the promotion of science
Japanese Governmental office
Japan
NO
福島県立医科大学
2018 | Year | 06 | Month | 01 | Day |
Published
https://doi.org/10.1002/cpt.2682
10
Completed
2018 | Year | 05 | Month | 23 | Day |
2018 | Year | 07 | Month | 01 | Day |
2018 | Year | 06 | Month | 01 | Day |
2022 | Year | 06 | Month | 30 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037438
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