serval:BIB_40E54B8E7B5F
The bioavailability of bromazepam, omeprazole and paracetamol given by nasogastric feeding tube.
10.1007/s00228-008-0613-4
000265440800001
19189088
Podilsky
G.
author
Berger-Gryllaki
M.
author
Testa
B.
author
Buclin
T.
author
Roulet
M.
author
Pannatier
A.
author
article
2009
European Journal of Clinical Pharmacology
1432-1041[electronic]
journal
65
5
435-442
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
eng
60_published
true
University of Lausanne
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