Bioequivalence of two oral formulations of nizatidine capsules in healthy male volunteers.
OBJECTIVE
The purpose of this randomized, crossover study was to compare the bioavailability of a generic and an innovator formulation of nizatidine 300 mg capsules under fasting conditions.


METHODS
Twenty blood samples per period were collected from 20 healthy, Arab male volunteers over 16 h, plasma nizatidine concentrations were determined by HPLC assay, and pharmacokinetic parameters were determined by the non-compartmental method.


RESULTS
Mean+/-SD C(max), T(max), AUC(0-->t), AUC(0-->infinity), and t1/2 were 2.96+/-0.54 and 3.28+/-0.68 microg/ml, 1.31+/-0.70 and 0.93+/-0.38 h, 9.04+/-1.66 and 9.03+/-1.94 microg x h/ml, 9.17+/-1.64 and 9.12+/-1.94 microg x h/ml, and 1.64+/-0.21 and 1.58+/-0.22 h for the generic and innovator formulation, respectively. The parametric 90% confidence intervals on the mean of the difference between log-transformed values were 98.06% to 103.21%, 98.74% to 103.71%, and 83.37% to 101.34%, for AUC(0-->t), AUC(0-->infinity), and C(max), respectively.


CONCLUSIONS
The results indicate that these two formulations are equivalent in the rate and extent of absorption.
Lockyer
Marilyn
M
Centre for Clinical Research, King Faisal Specialist Hospital and Research Centre, Riyadh, Saudi Arabia.
Al-Dgither
Saleh
S
Al-Gaai
Eman
E
Yousuf
Ahmed
A
Hammami
Muhammad M
MM
D000284:Administration, Oral; D000328:Adult; D001682:Biological Availability; D002851:Chromatography, High Pressure Liquid; D018592:Cross-Over Studies; D016568:Drugs, Generic; D006635:Histamine H2 Antagonists / Q000008:administration & dosage / Q000097:blood / Q000493:pharmacokinetics*; D006801:Humans; D008297:Male; D008875:Middle Aged; D016567:Nizatidine / Q000008:administration & dosage / Q000097:blood / Q000493:pharmacokinetics*; D013810:Therapeutic Equivalency
D016568:Drugs, Generic; D006635:Histamine H2 Antagonists; D016567:Nizatidine