Lansoprazole: administration of the contents of a capsule dosage formulation through a nasogastric tube.
A single-dose, open-label, randomized, crossover bioavailability study was conducted in 24 healthy adult male volunteers to assess an alternative method of administration of lansoprazole capsules. The results of 22 subjects were analyzed. Subjects received regimen A (granules from a 30-mg capsule mixed with apple juice and administered through a nasogastric tube) or regimen B (an intact 30-mg capsule) during the first study period. The regimens were reversed during the second period 1 week later. Blood samples were obtained over 12 hours and pharmacokinetic variables were determined. No statistically significant differences in mean time elapsed to peak concentration, mean peak concentration, area under the curve (AUC)0-t, and AUC0-infinity were detected between regimens by using analysis of variance. Bioavailability was assessed by the 90% confidence interval of the two one-sided tests on the natural logarithm of AUC. The 90% confidence interval for the AUCzero-infinity ratio was 0.955 to 1.140 for regimens A to B. These results indicate similar bioavailabilities between the two regimens and demonstrate that lansoprazole capsules may be administered by mixing the capsule contents with apple juice for administration through a nasogastric tube.
Chun
A H
AH
Pharmaceutical Products Division, Abbott Laboratories, Abbott Park, Illinois, USA.
Shi
H H
HH
Achari
R
R
Dennis
S
S
Cavanaugh
J H
JH
D053799:2-Pyridinylmethylsulfinylbenzimidazoles; D000328:Adult; D000897:Anti-Ulcer Agents / Q000008:administration & dosage / Q000493:pharmacokinetics; D001682:Biological Availability; D002214:Capsules; D018592:Cross-Over Studies; D006801:Humans; D007441:Intubation, Gastrointestinal; D064747:Lansoprazole; D008297:Male; D008875:Middle Aged; D009853:Omeprazole / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000097:blood / Q000493:pharmacokinetics
D053799:2-Pyridinylmethylsulfinylbenzimidazoles; D000897:Anti-Ulcer Agents; D002214:Capsules; D064747:Lansoprazole; D009853:Omeprazole