Cho, KyungJin
(Center for Nanotechnology-based New Drug Dosage Form, College of Pharmacy, Chungnam National University)
,
Cho, Wonkyung
(Center for Nanotechnology-based New Drug Dosage Form, College of Pharmacy, Chungnam National University)
,
Cha, KwangHo
(Center for Nanotechnology-based New Drug Dosage Form, College of Pharmacy, Chungnam National University)
,
Park, Junsung
(Center for Nanotechnology-based New Drug Dosage Form, College of Pharmacy, Chungnam National University)
,
Kim, MinSoo
(Center for Nanotechnology-based New Drug Dosage Form, College of Pharmacy, Chungnam National University)
,
Kim, JeongSoo
(Center for Nanotechnology-based New Drug Dosage Form, College of Pharmacy, Chungnam National University)
,
Hwang, SungJoo
(Center for Nanotechnology-based New Drug Dosage Form, College of Pharmacy, Chungnam National University)
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 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 serum concentrations 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 AUC0–24h, AUC0–fi1, Cmax, Tmax 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 AUC0fi1 and Cmax were log-transformed and tested parametrically by analysis of variance (ANOVA). 90% onfidence intervals of AUC0fi1 and Cmax ere 100.57%–109.56% and 105.46%–21.18%, respectively, and were in the ange of acceptable limits of bioequivalence 80–125%). Based on these results, he two formulations of itopride HCl are onsidered to be bioequivalent.
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 serum concentrations 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 AUC0–24h, AUC0–fi1, Cmax, Tmax 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 AUC0fi1 and Cmax were log-transformed and tested parametrically by analysis of variance (ANOVA). 90% onfidence intervals of AUC0fi1 and Cmax ere 100.57%–109.56% and 105.46%–21.18%, respectively, and were in the ange of acceptable limits of bioequivalence 80–125%). Based on these results, he two formulations of itopride HCl are onsidered to be bioequivalent.
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