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Research ArticleArticle

Population Pharmacokinetic Analysis of Daikenchuto, a Traditional Japanese Medicine (Kampo) in Japanese and US Health Volunteers

Masaya Munekage, Kengo Ichikawa, Hiroyuki Kitagawa, Kazuhisa Ishihara, Hideaki Uehara, Junko Watanabe, Toru Kono and Kazuhiro Hanazaki
Drug Metabolism and Disposition June 2013, 41 (6) 1256-1263; DOI: https://doi.org/10.1124/dmd.112.050112
Masaya Munekage
Department of Surgery, Kochi Medical School, Kochi, Japan (M.M., K.I., H.K., K.H.); Tsumura Laboratories, TSUMURA & CO., Ibaraki, Japan (J.W.); TSUMURA & CO., Tokyo, Japan (K.I., H.U.); and Advanced Surgery Center, Sapporo Higashi Tokushukai Hospital, Hokkaido, Japan (T.K.)
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Kengo Ichikawa
Department of Surgery, Kochi Medical School, Kochi, Japan (M.M., K.I., H.K., K.H.); Tsumura Laboratories, TSUMURA & CO., Ibaraki, Japan (J.W.); TSUMURA & CO., Tokyo, Japan (K.I., H.U.); and Advanced Surgery Center, Sapporo Higashi Tokushukai Hospital, Hokkaido, Japan (T.K.)
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Hiroyuki Kitagawa
Department of Surgery, Kochi Medical School, Kochi, Japan (M.M., K.I., H.K., K.H.); Tsumura Laboratories, TSUMURA & CO., Ibaraki, Japan (J.W.); TSUMURA & CO., Tokyo, Japan (K.I., H.U.); and Advanced Surgery Center, Sapporo Higashi Tokushukai Hospital, Hokkaido, Japan (T.K.)
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Kazuhisa Ishihara
Department of Surgery, Kochi Medical School, Kochi, Japan (M.M., K.I., H.K., K.H.); Tsumura Laboratories, TSUMURA & CO., Ibaraki, Japan (J.W.); TSUMURA & CO., Tokyo, Japan (K.I., H.U.); and Advanced Surgery Center, Sapporo Higashi Tokushukai Hospital, Hokkaido, Japan (T.K.)
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Hideaki Uehara
Department of Surgery, Kochi Medical School, Kochi, Japan (M.M., K.I., H.K., K.H.); Tsumura Laboratories, TSUMURA & CO., Ibaraki, Japan (J.W.); TSUMURA & CO., Tokyo, Japan (K.I., H.U.); and Advanced Surgery Center, Sapporo Higashi Tokushukai Hospital, Hokkaido, Japan (T.K.)
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Junko Watanabe
Department of Surgery, Kochi Medical School, Kochi, Japan (M.M., K.I., H.K., K.H.); Tsumura Laboratories, TSUMURA & CO., Ibaraki, Japan (J.W.); TSUMURA & CO., Tokyo, Japan (K.I., H.U.); and Advanced Surgery Center, Sapporo Higashi Tokushukai Hospital, Hokkaido, Japan (T.K.)
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Toru Kono
Department of Surgery, Kochi Medical School, Kochi, Japan (M.M., K.I., H.K., K.H.); Tsumura Laboratories, TSUMURA & CO., Ibaraki, Japan (J.W.); TSUMURA & CO., Tokyo, Japan (K.I., H.U.); and Advanced Surgery Center, Sapporo Higashi Tokushukai Hospital, Hokkaido, Japan (T.K.)
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Kazuhiro Hanazaki
Department of Surgery, Kochi Medical School, Kochi, Japan (M.M., K.I., H.K., K.H.); Tsumura Laboratories, TSUMURA & CO., Ibaraki, Japan (J.W.); TSUMURA & CO., Tokyo, Japan (K.I., H.U.); and Advanced Surgery Center, Sapporo Higashi Tokushukai Hospital, Hokkaido, Japan (T.K.)
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Abstract

We constructed population pharmacokinetic (PK) models for the five constituents of daikenchuto (DKT), a traditional Japanese herbal medicine. Data were collected from two randomized PK studies conducted in Japan and the United States. Participants received single oral doses of 2.5 g, 5 g, and 10 g of DKT. The plasma concentrations of five DKT constituents—hydroxy-α-sanshool (HAS), hydroxyl-β-sanshool (HBS), 6-shogaol (6S), 10-shogaol (10S), and ginsenoside Rb1 (GRB1)—were determined by liquid chromatography-tandem mass spectrometry. A total of 1859 samples from 55 participants (US, n = 36; Japanese, n = 19) were included in the analysis. Population PK models of HAS, HBS, 6S, and 10S were best described by a one or two-compartment model with a bolus input. On the other hand, the model of GRB1 was best described by a one-compartment model with nonlinear extravascular input. Among the covariates evaluated, body mass index (BMI) and age were found to influence oral clearance (CL/F) and volume of distribution (Vd/F) for HAS and HBS, respectively. The influence of body weight on CL/F and Vd/F for 6S was demonstrated. Marked differences were observed in mean plasma concentrations of HAS and HBS between Japanese and US participants. However, the simulation results indicated that the difference in plasma concentrations may be attributed to the difference in demographic factors such as BMI, body weight, and age, whereas ethnic difference between the Japanese and US participants was considered minimal.

Footnotes

    • Received November 15, 2012.
    • Accepted April 1, 2013.
  • This study was supported by a grant from TSUMURA & CO., Tokyo, Japan.

  • dx.doi.org/10.1124/dmd.112.050112.

  • ↵Embedded Image This article has supplemental material available at dmd.aspetjournals.org.

  • Copyright © 2013 by The American Society for Pharmacology and Experimental Therapeutics
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Drug Metabolism and Disposition: 41 (6)
Drug Metabolism and Disposition
Vol. 41, Issue 6
1 Jun 2013
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Research ArticleArticle

Population Pharmacokinetics of Daikenchuto Constituents

Masaya Munekage, Kengo Ichikawa, Hiroyuki Kitagawa, Kazuhisa Ishihara, Hideaki Uehara, Junko Watanabe, Toru Kono and Kazuhiro Hanazaki
Drug Metabolism and Disposition June 1, 2013, 41 (6) 1256-1263; DOI: https://doi.org/10.1124/dmd.112.050112

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Research ArticleArticle

Population Pharmacokinetics of Daikenchuto Constituents

Masaya Munekage, Kengo Ichikawa, Hiroyuki Kitagawa, Kazuhisa Ishihara, Hideaki Uehara, Junko Watanabe, Toru Kono and Kazuhiro Hanazaki
Drug Metabolism and Disposition June 1, 2013, 41 (6) 1256-1263; DOI: https://doi.org/10.1124/dmd.112.050112
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