Bioequivalence evaluation of lansoprazole 30-mg capsules (Lanfast and Lanzor) in healthy volunteers.
The bioequivalence of two lansoprazole 30-mg capsules was determined in healthy human, adult volunteers after a single dose in a randomized cross-over study. The study was conducted at Pharmaconsult, Flemington Pharmaceutical Corp., New Jersey, USA. Reference (Lanzor, Laboratoires Houde, Paris, France) and test (Lanfast, Julphar, UAE) were administered to volunteers with 240 ml water after overnight fasting. Blood samples were collected at specified time intervals, plasma was separated and analyzed for lansoprazole using a validated HPLC method. The pharmacokinetic parameters AUC(0-t), AUC(0-~), C(max), T(max), T(1/2) and elimination rate constant were determined from plasma concentration-time profile of both formulations and found to be in good agreement with previously reported values. The calculated pharmacokinetic parameters were compared statistically to evaluate bioequivalence between the two brands, using the statistical modules recommended by the Food and Drug Administration. The analysis of variance (ANOVA) did not show any significant difference between the two formulations and 90% confidence intervals fell within the acceptable range (80-120%) for bioequivalence. Based on these statistical inferences it was concluded that the two formulations exhibited comparable pharmacokinetic profiles and that Julphar's Lanfast is bioequivalent to Lanzor of Lab. Houde.
Pharmaconsult, Flemington Pharmaceutical Corp., Flemington, NJ, USA.
H A
HA
Dugger
J D
JD
Carlson
W
W
Henderson
G R
GR
Erdmann
S M
SM
Alam
R
R
Dham
Quamruzaman
D053799:2-Pyridinylmethylsulfinylbenzimidazoles; D000293:Adolescent; D000328:Adult; D000704:Analysis of Variance; D019540:Area Under Curve; D002214:Capsules; D002851:Chromatography, High Pressure Liquid / Q000379:methods; D018592:Cross-Over Studies; D006801:Humans; D064747:Lansoprazole; D008297:Male; D008875:Middle Aged; D015394:Molecular Structure; D009853:Omeprazole / Q000008:administration & dosage* / Q000031:analogs & derivatives* / Q000097:blood / Q000493:pharmacokinetics*; D013810:Therapeutic Equivalency
D053799:2-Pyridinylmethylsulfinylbenzimidazoles; D002214:Capsules; D064747:Lansoprazole; D009853:Omeprazole