title: The bioavailability of bromazepam, omeprazole and paracetamol given by nasogastric feeding tube.
abstract: OBJECTIVE
  To characterize and compare the pharmacokinetic profiles of bromazepam, omeprazole and paracetamol when administered by the oral and nasogastric routes to the same healthy cohort of volunteers.
  
  
  METHODS
  In a prospective, monocentric, randomized crossover study, eight healthy volunteers received the three drugs by the oral (OR) and nasogastric routes (NT). Sequential plasma samples were analyzed by high-performance liquid chromatography-UV, pharmacokinetic parameters (Cmax, AUC(0-infinity), t(1/2), k(e), tmax) were compared statistically, and Cmax, AUC(0-infinity) and t(max) were analyzed for bioequivalence.
  
  
  RESULTS
  A statistically significant difference was seen in the AUC(0-infinity) of bromazepam, with nasogastric administration decreasing availability by about 25%: AUC(OR) = 2501 ng mL(-1) h; AUC(NT) = 1855 ng mL(-1) h (p < 0.05); ratio (geometric mean) = 0.74 [90% confidence interval (CI) 0.64-0.87]. However, this does not appear to be clinically relevant given the usual dosage range and the drug's half-life (approx. 30 h). A large interindividual variability in omeprazole parameters prevented any statistical conclusion from being drawn in terms of both modes of administration despite their similar average profile: AUC(OR) = 579 ng mL(-1) h; AUC(NT) = 587 ng mL(-1) h (p > 0.05); ratio (geometric mean) = 1.01 (90% CI 0.64-1.61). An extended study with a larger number of subjects may possibly provide clearer answers. The narrow 90% confidence limits of paracetamol indicate bioequivalence: AUC(OR) = 37 microg mL(-1) h; AUC(NT) = 41 microg mL(-1) h(p > 0.05); ratio (geometric mean) = 1.12 (90% CI 0.98-1.28).
  
  
  CONCLUSIONS
  The results of this study show that the nasogastric route of administration does not appear to cause marked, clinically unsuitable alterations in the bioavailability of the tested drugs.
authors.affiliation: Department of Pharmacy, University Hospital Centre, Rue du Bugnon 46, Lausanne 1011, Switzerland.
authors.forename: Gregory
authors.initials: G
authors.lastname: Podilsky
authors.forename: Markoulina
authors.initials: M
authors.lastname: Berger-Gryllaki
authors.forename: Bernard
authors.initials: B
authors.lastname: Testa
authors.forename: Thierry
authors.initials: T
authors.lastname: Buclin
authors.forename: Michel
authors.initials: M
authors.lastname: Roulet
authors.forename: Andre
authors.initials: A
authors.lastname: Pannatier
mesh_terms: D000082:Acetaminophen / Q000008:administration & dosage / Q000097:blood / Q000493:pharmacokinetics*; D000284:Administration, Oral; D018712:Analgesics, Non-Narcotic / Q000008:administration & dosage / Q000097:blood / Q000493:pharmacokinetics*; D014151:Anti-Anxiety Agents / Q000008:administration & dosage / Q000097:blood / Q000493:pharmacokinetics*; D000897:Anti-Ulcer Agents / Q000008:administration & dosage / Q000097:blood / Q000493:pharmacokinetics*; D019540:Area Under Curve; D001682:Biological Availability; D001960:Bromazepam / Q000008:administration & dosage / Q000097:blood / Q000493:pharmacokinetics*; D015331:Cohort Studies; D018592:Cross-Over Studies; D005260:Female; D006207:Half-Life; D006801:Humans; D007441:Intubation, Gastrointestinal; D008297:Male; D008657:Metabolic Clearance Rate; D009853:Omeprazole / Q000008:administration & dosage / Q000097:blood / Q000493:pharmacokinetics*; D011446:Prospective Studies; D015203:Reproducibility of Results; D013810:Therapeutic Equivalency
chemical_list: D018712:Analgesics, Non-Narcotic; D014151:Anti-Anxiety Agents; D000897:Anti-Ulcer Agents; D000082:Acetaminophen; D009853:Omeprazole; D001960:Bromazepam