Lansoprazole pharmacokinetics differ in patients with oesophagitis compared to healthy volunteers.
OBJECTIVE
To compare the pharmacokinetics of lansoprazole in patients with reflux oesophagitis and in healthy volunteers, after a single dose and at steady-state.


METHODS
A 30 mg dose of lansoprazole was administered orally daily for 7 days in eight healthy male volunteers aged 21-24 years, and in 16 patients aged 29-65 years with grade 2 or 3 reflux oesophagitis. The pharmacokinetics were assessed over the 24 h dose interval following the first dose and again after the 7th dose.


RESULTS
Within both the patient and volunteers groups, there were no significant differences between day 1 and day 7 in any of the pharmacokinetic parameters including maximum concentration (Cmax), area under the concentration-time curve (AUC), and terminal half-life of elimination (t(1/2)). However, on both days 1 and 7, values were significantly higher in the patients than in the healthy volunteers. On day 7, Cmax was 1343 ng/mL in patients compared with 765 ng/mL in healthy volunteers, AUC was 3458 ng.h/mL vs. 1350 ng.h/mL and t(1/2) was 1.62 h vs. 0.90 h.


CONCLUSIONS
The differences in results for the pharmacokinetics reflect reduced lansoprazole clearance in the patient group. Other research has not found a difference in pharmacokinetics when comparing healthy volunteers with patients with acid-related disorders. The difference in lansoprazole clearance in this study may be related to a variety of factors that are different in patients compared with young normal volunteers, such as age, gender, other drugs, and reduced general well-being.
Barclay
M L
ML
Department of Clinical Pharmacology, Christchurch Hospital, Christchurch, New Zealand.
Begg
E J
EJ
Robson
R A
RA
Peters
W A
WA
Ketelbey
J W
JW
D053799:2-Pyridinylmethylsulfinylbenzimidazoles; D000328:Adult; D000897:Anti-Ulcer Agents / Q000008:administration & dosage / Q000097:blood / Q000493:pharmacokinetics*; D019540:Area Under Curve; D002851:Chromatography, High Pressure Liquid; D004334:Drug Administration Schedule; D004791:Enzyme Inhibitors / Q000008:administration & dosage / Q000097:blood / Q000493:pharmacokinetics*; D004942:Esophagitis, Peptic / Q000188:drug therapy / Q000378:metabolism*; D005260:Female; D006801:Humans; D064747:Lansoprazole; D016014:Linear Models; D008297:Male; D008875:Middle Aged; D009853:Omeprazole / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000097:blood / Q000493:pharmacokinetics; D054328:Proton Pump Inhibitors; D012016:Reference Values
D053799:2-Pyridinylmethylsulfinylbenzimidazoles; D000897:Anti-Ulcer Agents; D004791:Enzyme Inhibitors; D054328:Proton Pump Inhibitors; D064747:Lansoprazole; D009853:Omeprazole