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타이레놀이알서방정(아세트아미노핀 650 mg)에 대한 타이리콜이알정의 생물학적동등성
강현아,김동호,박선애,윤화,김경란,박은자,조혜영,이용복,Kang, Hyun-Ah,Kim, Dong-Ho,Park, Sun-Ae,Yun, Hwa,Kim, Kyung-Ran,Park, Eun-Ja,Cho, Hea-Yeong,Lee, Yong-Bok 한국약제학회 2006 Journal of Pharmaceutical Investigation Vol.36 No.3
Acetaminophen (paracetamol), a para-aminophenol derivative, has analgesic and antipyretic properties and weak anti-inflammatory activity. The purpose of the present study was to evaluate the bioequivalence of two acetaminophen tablets, $Tylenol^{\circledR}$ ER (Janssen Korea Ltd.) and Tylicol ER (Hana Pharmaceutical Co., Ltd.), according to the guidelines of the Korea Food and Drug Administration (KFDA). The release of acetaminophen from the two acetaminophen formulations in vitro was tested using KP VIll Apparatus II method with pH 1.2 buffer solution. Twenty six healthy male subjects, $22.8{\pm}1.99$ years in age and $65.6{\pm}8.03$ kg in body weight, were divided into two groups and a randomized $2{\times}2$ cross-over study was employed. After a single tablet containing 650 mg as acetaminophen was orally administered, blood samples were taken at predetermined time intervals and the concentrations of acetaminophen in serum were determined using HPLC with UV detector. The dissolution profiles of two formulations were similar in pH 1.2 buffer solution. The pharmacokinetic parameters such as $AUC_t$, $C_{max}$ and $T_{max}$ were calculated and ANOVA test was utilized for the statistical analysis of the parameters using logarithmically transformed $AUC_t$, $C_{max}$ and untransformed $T_{max}$. The results showed that the differences between two formulations based on the reference drug, $Tylenol^{\circledR}$ ER, were 2.84, 1.89 and -1.36% for $AUC_t$, $C_{max}$ and $T_{max}$, respectively. There were no sequence effects between two formulations in these parameters. The 90% confidence intervals using logarithmically transformed data were within the acceptance range of log 0.8 to log 1.25 (e.g., log $0.987{\sim}log$ 1.08 and log $0.944{\sim}log$ 1.17 for $AUC_t$ and $C_{max}$, respectively). Thus, the criteria of the KFDA bioequivalence guideline were satisfied, indicating Tylicol ER tablet was bioequivalent to $Tylenol^{\circledR}$ ER tablet.
단보 : 솔레톤 정(잘토프로펜 80 ㎎)에 대한 삼천당잘토프로펜 정의 생물학적동등성
강현아 ( Hyun Ah Kang ),박선애 ( Sun Ae Park ),김동호 ( Dong Ho Kim ),김환호 ( Hwan Ho Kim ),윤화 ( Hwa Yun ),김경란 ( Kyung Ran Kim ),류희두 ( Hee Doo Yoo ),박은자 ( Eun Ja Park ),조혜영 ( Hea Young Cho ),이용복 ( Yong Bok Lee ) 한국약제학회 2006 Journal of Pharmaceutical Investigation Vol.36 No.3