Article: article from journal or magazin.
The bioavailability of bromazepam, omeprazole and paracetamol given by nasogastric feeding tube.
European Journal of Clinical Pharmacology
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.
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
Web of science
Last modification date