Pharmacokinetic and bioequivalence study of itopride HCl in healthy volunteers

Kyung Jin Cho, Wonkyung Cho, Kwang Ho Cha, Junsung Park, Min Soo Kim, Jeong Soo Kim, Sung Joo Hwang

Research output: Contribution to journalArticle

2 Citations (Scopus)

Abstract

In the present study two different formulations containing 50 mg itopride HCl (N-[4-[2-(dimethylamino)ethoxy]benzyl]-3,4-dimethoxybenzamide HCl, CAS 122898- 67-3) were compared in 28 healthy male volunteers in order to compare the bioavailability and prove the bioequivalence. The study was performed in an open, single dose randomized, 2-sequence, crossover design in 28 healthy male volunteers with a one-week washout period. Blood samples for pharmacokinetic profiling were drawn at selected times during 24 h. The serumconcentrations of itopride HCl were determined using a specific and sensitive HPLC method with fluorescence detection. The detection limit of itopride HCl was 5 ng/ml and no endogenous compounds were found to interfere with analysis. The mean AUC 0→24h, AUC0→∞, Cmax, T max and T1/2 were 865.28 ng · h/ml, 873.04 ng · h/ml, 303.72 ng/ml, 0.75 h, and 2.95 h, respectively, for the test formulations, and 833.00 ng · h/ml, 830.97 ng · h/ml, 268.01 ng/ml, 0.78 h, and 2.83 h, respectively, for the reference formulation. Both primary target parameters AUC0→∞ and Cmax were log-transformed and tested parametrically by analysis of variance (ANOVA). 90% confidence intervals of AUC0→∞ and Cmax were 100.57%-109.56% and 105.46%-121.18%, respectively, and were in the range of acceptable limits of bioequivalence (80-125%). Based on these results, the two formulations of itopride HCl are considered to be bioequivalent.

Original languageEnglish
Pages (from-to)137-140
Number of pages4
JournalArzneimittel-Forschung/Drug Research
Volume60
Issue number3
DOIs
Publication statusPublished - 2010

All Science Journal Classification (ASJC) codes

  • Drug Discovery

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