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The bioavailability of bromazepam, omeprazole and paracetamol given by nasogastric feeding tube.

Authors
Journal
European Journal of Clinical Pharmacology
0031-6970
Publisher
Springer-Verlag
Publication Date
Volume
65
Issue
5
Identifiers
DOI: 10.1007/s00228-008-0613-4
Keywords
  • Acetaminophen/Administration & Dosage
  • Acetaminophen/Blood
  • Administration
  • Oral
  • Analgesics
  • Non-Narcotic/Administration & Dosage
  • Analgesics
  • Non-Narcotic/Blood
  • Anti-Anxiety Agents/Administration & Dosage
  • Anti-Anxiety Agents/Blood
  • Anti-Ulcer Agents/Administration & Dosage
  • Anti-Ulcer Agents/Blood
  • Area Under Curve
  • Biological Availability
  • Bromazepam/Administration & Dosage
  • Bromazepam/Blood
  • Cohort Studies
  • Cross-Over Studies
  • Female
  • Half-Life
  • Humans
  • Intubation
  • Gastrointestinal
  • Male
  • Metabolic Clearance Rate
  • Omeprazole/Administration & Dosage
  • Omeprazole/Blood
  • Prospective Studies
  • Reproducibility Of Results
  • Therapeutic Equivalency
Disciplines
  • Mathematics
  • Pharmacology

Abstract

AIMS: 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). CONCLUSION: 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.

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