title: Comparison of the effects of fasting morning, fasting evening and fed bedtime administration of tenatoprazole on intragastric pH in healthy volunteers: a randomized three-way crossover study.
abstract: BACKGROUND
  The effectiveness of proton pump inhibitors is influenced by meals and administration time.
  
  
  OBJECTIVE
  To compare the effects on intragastric acidity of times of dosing of tenatoprazole, a novel imidazopyridine-based proton pump inhibitor with a prolonged plasma half-life.
  
  
  METHODS
  This randomized three-period crossover study included 12 Helicobacter pylori-negative healthy subjects, who received tenatoprazole 40 mg either fasting at 7.00 AM, fasting at 7.00 PM or fed at 9.30 PM for 7 days, with a 2-week washout between periods. Twenty-four hour intragastric pH was monitored on day 7 of each period.
  
  
  RESULTS
  On day 7, median 24-h pH was 4.7, 5.1 and 4.7 after breakfast, dinner and bedtime dosing, respectively (P = 0.11), whereas night-time pH was 4.2, 5.0 and 4.4 (P = 0.13). The mean 24-h percentage of time over pH 4 was 62, 72 and 64 after breakfast, dinner and bedtime dosing, respectively (N.S.), and 54, 68 and 56 during night-time (P = 0.06). Nocturnal acid breakthrough incidence decreased from 100% at baseline to 83%, 55% and 75% after 7.00 AM, 7.00 PM and 9.30 PM dosing, respectively (P = 0.18), and its mean duration dropped from 6.2 to 2.8, 1.0 and 2.2 h, respectively (P < 0.05).
  
  
  CONCLUSIONS
  Seven-day administration of tenatoprazole provides a prolonged duration of acid suppression, especially during the night-time, with little effect of food or time of dosing.
authors.affiliation: Department of Medicine, Division of Gastroenterology, University of Alberta, Edmonton, Canada. alan.thomson@ualberta.ca
authors.forename: A B R
authors.initials: AB
authors.lastname: Thomson
authors.forename: P
authors.initials: P
authors.lastname: Cohen
authors.forename: H
authors.initials: H
authors.lastname: Ficheux
authors.forename: P
authors.initials: P
authors.lastname: Fiorentini
authors.forename: F
authors.initials: F
authors.lastname: Domagala
authors.forename: M
authors.initials: M
authors.lastname: Homerin
authors.forename: A
authors.initials: A
authors.lastname: Taccoen
mesh_terms: D053799:2-Pyridinylmethylsulfinylbenzimidazoles; D000293:Adolescent; D000328:Adult; D000704:Analysis of Variance; D000897:Anti-Ulcer Agents / Q000097:blood / Q000493:pharmacokinetics / Q000494:pharmacology*; D002940:Circadian Rhythm; D018592:Cross-Over Studies; D004334:Drug Administration Schedule; D004435:Eating; D005215:Fasting; D005745:Gastric Acidity Determination; D005750:Gastric Juice / Q000378:metabolism*; D006801:Humans; D006863:Hydrogen-Ion Concentration; D007093:Imidazoles / Q000097:blood / Q000493:pharmacokinetics / Q000494:pharmacology*; D008297:Male; D009853:Omeprazole / Q000031:analogs & derivatives* / Q000097:blood / Q000493:pharmacokinetics / Q000494:pharmacology; D011725:Pyridines / Q000097:blood / Q000493:pharmacokinetics / Q000494:pharmacology*; D018709:Statistics, Nonparametric
chemical_list: D053799:2-Pyridinylmethylsulfinylbenzimidazoles; D000897:Anti-Ulcer Agents; D007093:Imidazoles; D011725:Pyridines; D009853:Omeprazole; C119998:Tenatoprazole