title: Effect of calcium supplements on the oral bioavailability of moxifloxacin in healthy male volunteers.
abstract: OBJECTIVE
  To investigate the effect of concomitant calcium administration on the pharmacokinetics and tolerability of moxifloxacin.
  
  
  METHODS
  This was a nonblinded, randomised, single dose, crossover study in healthy male volunteers.
  
  
  METHODS
  12 healthy male Caucasians (age 24 to 45 years) were enrolled in the study.
  
  
  METHODS
  In each of the 2 study periods, each volunteer received a single oral morning dose of moxifloxacin 400mg after an overnight fast. In 1 of the study periods, Ca2+ 500mg (Calcium-Sandoz Forte) was administered immediately before, and 12 and 24 hours after, moxifloxacin (total of 3 doses of Ca2+). The 2 study periods were separated by a washout period of at least 2 weeks.
  
  
  RESULTS
  Moxifloxacin was well tolerated throughout the study. There was no difference in the area under the plasma concentration-time curve from zero to infinity [AUCinfinity; geometric mean (SD)] of moxifloxacin [32.2 (1.24) vs 33.0 (1.26) mg/L x h, with vs without Ca2+]. Maximum plasma concentration (Cmax) [2.29 (1.27) vs 2.71 (1.33) mg/L, with vs without Ca2+] slightly decreased by approximately 16% and the time to Cmax [median (range)] tended to be slightly prolonged [2.5 (0.8 to 3) vs 0.9 (0.5 to 2.5) hours, with vs without Ca2+].
  
  
  CONCLUSIONS
  The extent of absorption of moxifloxacin is not affected by concomitant Ca2+ intake, whereas the rate of absorption is slightly reduced, an effect not considered to be of clinical relevance. Hence, moxifloxacin may be administered together with Ca2+ without dosage adjustments or special recommendations.
authors.affiliation: Pharma Research Centre, Institute of Clinical Pharmacology, Bayer AG, Wuppertal, Germany. Heino.Stass.hs@bayer-ag.de
authors.forename: H
authors.initials: H
authors.lastname: Stass
authors.forename: C
authors.initials: C
authors.lastname: Wandel
authors.forename: H
authors.initials: H
authors.lastname: Delesen
authors.forename: J G
authors.initials: JG
authors.lastname: Möller
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000704:Analysis of Variance; D000890:Anti-Infective Agents / Q000493:pharmacokinetics*; D019540:Area Under Curve; D001372:Aza Compounds; D001682:Biological Availability; D002118:Calcium / Q000494:pharmacology*; D018592:Cross-Over Studies; D004347:Drug Interactions; D024841:Fluoroquinolones; D006207:Half-Life; D006801:Humans; D007408:Intestinal Absorption / Q000187:drug effects; D016014:Linear Models; D008297:Male; D000077266:Moxifloxacin; D011804:Quinolines
chemical_list: D000890:Anti-Infective Agents; D001372:Aza Compounds; D024841:Fluoroquinolones; D011804:Quinolines; D002118:Calcium; D000077266:Moxifloxacin