title: Pharmacokinetic comparison of ginsenoside metabolite IH-901 from fermented and non-fermented ginseng in healthy Korean volunteers.
abstract: BACKGROUND
  IH-901 (20-O-beta-D-glucopyranosyl-20(S)-protopanaxadiol) is a novel ginseng saponin metabolite formed by human intestinal bacteria and is known to have antitumor and antimetastatic effects. However, there has been no pharmacokinetic study of IH-901 in human beings.
  
  
  OBJECTIVE
  The aim of this study was to investigate the pharmacokinetic differences of IH-901 from fermented and non-fermented ginseng.
  
  
  METHODS
  To investigate whether the pharmacokinetics of IH-901 differ between fermented and non-fermented ginseng, an open label, randomized, single dose, fasting, two-period, cross-over, pharmacokinetic study was conducted. A total of 24 healthy Korean male volunteers participated in this study. All subjects were allocated into two equal groups and administered 3g of fermented or non-fermented Panax ginseng. Serial blood samples for pharmacokinetic analysis were collected in the 24 h after dosing. Plasma IH-901 concentration was measured by a validated high-performance liquid chromatography-tandem mass spectrometry (LC-MS/MS) method. Pharmacokinetic parameters including AUC(t), C(max), and T(max) were calculated by noncompartmental models in the BA-CALC program (KFDA, 2008, 1.0.0, Korea).
  
  
  RESULTS
  After oral administration of fermented ginseng, 5 subjects experienced diarrhea. The means of AUC(t) and C(max) were significantly different between the two groups. In the fermented ginseng group, AUC(t) was 2083.09±91.97 ng h/mL, a 15.5-fold increase over that of IH-901 from the non-fermented group (134.50±63.10 ng h/mL), and the mean C(max) was 325.00±91.97 ng/mL in the fermented ginseng group, a 27-fold higher value than that in the non-fermented group (13.88±7.24 ng/mL). T(max) was 3.29±1.00 and 12.04±4.96 h in the fermented and non-fermented group, respectively.
  
  
  CONCLUSIONS
  The results of this study showed that the pharmacokinetic parameters of IH-901 from fermented Panax ginseng are different from those of non-fermented ginseng, from which IH-901 is formed by intestinal fermentation.
authors.affiliation: Department of Clinical Pharmacology, College of Medicine, Kyung Hee University, Seoul, Republic of Korea.
authors.forename: Hui
authors.initials: H
authors.lastname: Jin
authors.forename: Ji-Hyung
authors.initials: JH
authors.lastname: Seo
authors.forename: Yoon-Kyung
authors.initials: YK
authors.lastname: Uhm
authors.forename: Chae-Young
authors.initials: CY
authors.lastname: Jung
authors.forename: Seung-Kwon
authors.initials: SK
authors.lastname: Lee
authors.forename: Sung-Vin
authors.initials: SV
authors.lastname: Yim
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000972:Antineoplastic Agents, Phytogenic / Q000008:administration & dosage / Q000009:adverse effects / Q000097:blood / Q000493:pharmacokinetics*; D044466:Asian People; D001419:Bacteria / Q000378:metabolism*; D002851:Chromatography, High Pressure Liquid; D018592:Cross-Over Studies; D005285:Fermentation; D006801:Humans; D007422:Intestines / Q000382:microbiology*; D008297:Male; D008875:Middle Aged; D008954:Models, Biological; D005894:Panax; D028321:Plant Preparations / Q000008:administration & dosage / Q000009:adverse effects / Q000097:blood / Q000493:pharmacokinetics*; D010946:Plants, Medicinal; D015203:Reproducibility of Results; D056910:Republic of Korea / Q000453:epidemiology; D012502:Sapogenins / Q000008:administration & dosage / Q000009:adverse effects / Q000097:blood / Q000493:pharmacokinetics*; D053719:Tandem Mass Spectrometry; D055815:Young Adult
chemical_list: C482402:20-O-(beta-D-glucopyranosyl)-20(S)-protopanaxadiol; D000972:Antineoplastic Agents, Phytogenic; D028321:Plant Preparations; D012502:Sapogenins