title: Bioequivalence of two oral formulations of nizatidine capsules in healthy male volunteers.
abstract: 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.
authors.affiliation: Centre for Clinical Research, King Faisal Specialist Hospital and Research Centre, Riyadh, Saudi Arabia.
authors.forename: Marilyn
authors.initials: M
authors.lastname: Lockyer
authors.forename: Saleh
authors.initials: S
authors.lastname: Al-Dgither
authors.forename: Eman
authors.initials: E
authors.lastname: Al-Gaai
authors.forename: Ahmed
authors.initials: A
authors.lastname: Yousuf
authors.forename: Muhammad M
authors.initials: MM
authors.lastname: Hammami
mesh_terms: 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
chemical_list: D016568:Drugs, Generic; D006635:Histamine H2 Antagonists; D016567:Nizatidine