|
KMID : 0614020020170010096
|
|
Journal of Pharmaceutical Sciences (C.N.U.)
2002 Volume.17 No. 1 p.96 ~ p.105
|
|
|
Bioequivalence of Hanmi Domperidone Tablets to Motilium-M Tablets (Domperidone Maleate 12.72 mg)
|
|
Kwak Son-Hyok
Woo Jong-Soo
Hwang Sung-Joo
|
|
|
Abstract
|
|
|
|
Bioequivalence of two domperidone maleate tablets, test drug (Hanmi Domperidone^ⓡ tablet: Hanmi Pharmaceutical Co.) and reference drug (Motilium-M^ⓡ tablet: Jassen Korea Pharm. Co.), was evaluated according to the guidelines of Korea Food and Drug Administration (KFDA). Twenty four healthy male volunteers were divided randomly into two groups and administered the drug orally at the dose of 20㎎ as domperidone in a 2×2 crossover study. There was a week washout period between administrations. Blood samples were taken at predetermined time intervals for 48hr and the plasma concentration of domperidone was determined by a HPLC method. AUC_0-48hr (area under the plasma concentration-time curve from time zero to 48hr), C_max (maximum plasma drug concentration) and T_max, (time to reach C_max) were estimated from the plasma drug concentration-time data. Analysis of variance (ANOVA) revealed no difference in AUC_0-48hr, C_max and T_max between two products. The apparent differences of these parameters between two products were less than 20% (i.e., 1.047, -0.416 and 9.347% for AUC_0-10hr, C_max and T_max, respectively). The powers (1-β) for AUC_0-48hr, C_max and T_max were over 0.99. Minimal detectable differences (Δ) at α=0.05, 1-β=0.8 were less than 20% (i.e. 11.15, 10.21 and 18.13% for AUC_0-10hr, C_max and T_max respectively). The 95% Confidence intervals (δ) for these parameters were also within ±20% (i.e. -5.49≤δ≤7.58, -6.39≤δ≤5.57 and -1.28≤δ≤19.95 for AUC_0-10hr, C_max and T_max, respectively). These results satisfied the criteria of KFDA guidelines for bioequivalence, indicating the two tablets of domperidone maleate were bioequivalent.
|
|
|
KEYWORD
|
|
|
Bioequivalence, domperidone maleate, Motilium-M^?, Hanmi Domperidone^?, HPLC
|
|
|
FullTexts / Linksout information
|
|
|
|
|
|
Listed journal information
|
|
|
|
|