title: Pharmacokinetics and safety of single and multiple doses of Asacol tablets in Japanese healthy volunteers.
abstract: BACKGROUND
  The pharmacokinetics and safety of Asacol (Tillotts Pharma AG, Ziefen, Switzerland), which has been used worldwide to treat ulcerative colitis and Crohn's disease, were studied in Japanese healthy male volunteers.
  
  
  METHODS
  Drug plasma concentrations and urinary and fecal excretions after a single dose (400-4800 mg) and multiple doses (3600 mg/day for 7 days) were investigated.
  
  
  RESULTS
  All adverse events were "not serious." The peak plasma concentration (C max) was reached at 12.3-18.0 hours after a single dose, and the C max and area under the plasma concentration-time curve (AUC) of mesalazine and its N-acetyl metabolite were proportional to the doses. The C max and AUC in non-Japanese subjects reported in the literature were closely correlated to findings in Japanese subjects, and external excretions were also similar in the Japanese and non-Japanese subjects.
  
  
  CONCLUSIONS
  Asacol was safe and well tolerated in this Japanese population, and the non-Japanese clinical data could be extrapolated to the Japanese population.
authors.affiliation: Digestive Disease Center of Excellence, Kitano Hospital, The Tazuke Kofukai Medical Research Institute, Kita-ku, Osaka, Japan.
authors.forename: Hiroaki
authors.initials: H
authors.lastname: Ito
authors.forename: Shigeru
authors.initials: S
authors.lastname: Furuta
authors.forename: Hidetaka
authors.initials: H
authors.lastname: Sasaki
authors.forename: Toyomitsu
authors.initials: T
authors.lastname: Yoshida
authors.forename: Yuichi
authors.initials: Y
authors.lastname: Takano
authors.forename: Toshifumi
authors.initials: T
authors.lastname: Hibi
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage / Q000378:metabolism / Q000493:pharmacokinetics*; D019540:Area Under Curve; D003093:Colitis, Ulcerative / Q000188:drug therapy; D003424:Crohn Disease / Q000188:drug therapy; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D016903:Drug Monitoring; D018565:Food-Drug Interactions; D006801:Humans; D007564:Japan; D008297:Male; D019804:Mesalamine / Q000008:administration & dosage / Q000378:metabolism / Q000493:pharmacokinetics*; D008657:Metabolic Clearance Rate; D008875:Middle Aged; D012449:Safety; D013607:Tablets; D013997:Time Factors
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D013607:Tablets; D019804:Mesalamine