시험관내 용출 및 장관막투과도와 생체이용률과의 상관성 연구

서수경(Soo Kyung Suh),양지선(Ji Sun Yang),손수정(Soo Jung Sohn),박인숙(In Sook Park),조혜영(Hea Young Cho),심영순(Young Sun Shim),이용복(Yong Bok Lee) 한국약제학회 1999 한국약제학회 총회 및 학술대회 요지집 Vol.- No.29

N/A N/A

니세틸 정(아세틸-엘-카르니틴 500 mg)에 대한 뉴로세틸 정의 생물학적 동등성

조혜영,김은아,정현철,심영순,임동구,오인준,문재동,이용복 전남대학교 약품개발연구소 2001 약품개발연구지 Vol.10 No.-

Acetyl-L-carnitine (ALC), an endogenous component of the L-carnitine family, is naturally occurring molecule synthesized from L-carnitine (LC) by carnitine acetyl transferase. ALC has been shown to improve the cognitive performance of patients suffering from dementia of the Alzheimer's type and proposed for treating Alzheimer's disease in pharmacological doses. The purpose of the present study was to evaluate the bioequivalence of two ALC tablets, Nicetiler^TM (Dong-A pharmaceutical Co., Ltd.) and Neurocetil^TM (Kyung-Dong Pharmaceutical Co., Ltd.), according to the guidelines of Korea Food and Drug Administration. Twenty six normal male volunteers, 22.80±2.76 year in age and 63.07 7.98㎏ in body weight, were divided into two groups and a randomized 2×2 cross-over study was employed. After one tablet containing 500㎎ of ALC was orally administered, blood was taken at predetermined time intervals and the concentrations of ALC in serum were determined using HPLC with fluorescence detector. Because of the presence of endogenous ALC, the calibration was performed using dialyzed serum. Pharmacokinetic parameters such as AUC_t, C_max and T_max were calculated and ANOVA was utilized for the statistical analysis of the parameters. The results showed that the differences in AUC_t, C_max and T_max between two tablets were 2.72%, -0.65% and -8.42%, respectively, when calculated against the Nicetile^TM tablet. The powers (1-β) for AUC_t and C_max were 94.87% and 87.17%, respectively. Minimum detectable differences (Δ) at α=0.05 and 1-β=0.8 were less than 20% (e.g., 15.58% and 19.16% AUC_t and C_max, respectively). The 90% confidence intervals were within ±20% (e.g., -11.84∼6.41 and -10.57∼11.88 for AUC_t and C_max, respectively). Two parameters met the criteria of KFDA for bioequivalence, indicating that Neurocetil^TM tablet is bioequivalent to Nicetile^TM tablet.

디스그렌 캅셀(트리플루살 300 mg)에 대한 티그린 캅셀의 생물학적 동등성

김수진,심영순,손선미,임동구,문재동,이용복 전남대학교 약품개발연구소 1999 약품개발연구지 Vol.8 No.1

Triflusal is a new antithrombotic agent which inhibits both platelet cyclooxygenase and c-AMP phosphodiesterase activity. The purpose of the present study was to evaluate the bioequivalence of two triflusal capsules, Disgren^(TM) (Myung-In Pharmaceutical Co., Ltd.) and Tigrin^(TM) (Hana Pharmaceutical Co., Ltd.) according to the guidelines of Korea Food and Drug Administration (KFDA). Eighteen normal male volunteers, 22.94±11.83 in age and 63.71±10.43 ㎏ in body weight, were divided into two groups and a randomized 2×2 cross-over study was employed. After one capsule containing 300 ㎎ of triflusal was orally administered, blood was taken at predetermined time intervals and the concentrations of triflusal in serum were determined using HPLC method with UV detector 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. The results showed that the differences in AUC_t, C_(max) and T_(max) between two capsules were -0.30%, 0.81% and -3.03%, respectively when calculated against the Disgren^(TM) capsule. The powers (1-β) for AUC_t, C_(max) and T_(max) were 98.29%, 84.73% and 81.02%, respectively. Minimum detectable differences (Δ) at α=0.1 and 1-β=0.8 were all less than 20% (e.g., 12.91%, 18.46% and 19.65% for AUC_t, C_(max) and T_(max) respectively). The 90% confidence intervals were all within ±20%(e.g., -8.97∼8.37. -11.58∼13.22 and -16.23∼10.17 for AUC_t, C_(max) and T_(max) respectively). All of the above parameters (1-β, Δ and 90% confidence intervals) met the criteria of KFDA for bioequivalence, indicating that Tigrin^(TM) capsule is bioequivalent to Disgren^(TM) capsule.

디스그렌 캅셀(트리플루살 300mg)에 대한 티그린 캅셀의 생물학적 동등성

김수진,심영순,손선미,임동구,문재동,이용복 전남대학교 약품개발연구소 2000 약품개발연구지 Vol.9 No.1

Triflusal is a new antithrombotic agent which inhibits both platelet cyclooxygenase and c-AMP phosphodiesterase activity. The purpose of the present study was to evaluate the bioequivalence of two triflusal capsules, Disgren^(TM) (Myung-In Pharmaceutical Co., Ltd.) and Tigrin^(TM) (Hens Pharmaceutical Co., Ltd.) according to the guidelines of Korea Food and Drug Administration (KFDA). Eighteen normal male volunteers, 22.94±1.83 in age and 63.71±10.43 ㎏ in body weight, were divided into two groups and a randomized 2×2 cross-over study was employed. After one capsule containing 300 ㎎ of triflusal was orally administered, blood was taken at predetermined time intervals and the concentrations of triflusal in serum were determined using HPLC method with UV detector. 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. The results showed that the differences in AUC_t, C_(max) and T_(max) , between two capsules were -0.30%, 0.81% and -3.03%, respectively when calculated against the Disgren^(TM) capsule. The powers (1-β) for AUC_t, C_(max) and T_(max) , were 98.29%, 84.73% and 81.02%, respectively. Minimum detectable differences (Δ) at α=0.1 and 1-β=0.8 were all less than 20% (e.g.. 12.91%, 18.46% and 19.65% for AUC_t, C_(max) and T_(max), respectively). The 90% confidence intervals were all within 120%(e.g., -8.97∼8.37, -11.58∼13.22 and -16.23-10.17 for AUC_t, C_(max) and T_(max) , respectively). All of the above parameters (1-β, Δ and 90% confidence intervals) met the criteria of KFDA for bioequivalence, indicating that Tigrin^(TM) capsule is bioequivalent to Disgren^(TM) capsule.

니세틸 정(아세틸 - 엘 - 카르니틴 500mg)에 대한 뉴로세틸 정의 생물학적 동등성

조혜영,오인준,이용복,임동구,문재동,심영순,김은아,정현철 한국약제학회 2001 Journal of Pharmaceutical Investigation Vol.31 No.1

Acetyl-L-carnitine (ALC), an endogenous component of the L-carnitine family, is naturally occurring molecule synthesized from L-carnitine (LC) by carnitine acetyl transferase. ALC has been shown to improve the cognitive performance of patients suffering from dementia of the Alzheimer's type and proposed for treating Alzheimer's disease in pharmacological doses. The purpose of the present study was to evaluate the bioequivalence of two ALC tablets, Nicetile^(TM) (Dong-A pharmaceutical Co., Ltd.) and Neurocetil^(TM) (Kyung-Dong Pharmaceutical Co., Ltd.), according to the guidelines of Korea Food and Drug Administration. Twenty six normal male volunteers, 22.80±2.76 year in age and 63.07±7.98 ㎏ in body weight, were divided into two groups and a randomized 2 × 2 cross-over study was employed. After one tablet containing 500 ㎎ of ALC was orally administered, blood was taken at predetermined time intervals and the concentrations of ALC in serum were determined using HPLC with fluorescence detector. Because of the presence of endogenous ALC, the calibration was performed using dialyzed serum. Pharmacokinetic parameters such as AUC_t, C_(max) and T_(max) were calculated and ANOVA was utilized for the statistical analysis of the parameters. The results showed that the differences in AUC_t, C_(max) and T_(max) between two tablets were 2.72%, -0.65% and -8.42%, respectively, when calculated against the Nicetile^(TM) tablet. The powers (1-β) for AUC_t and C_(max) were 94.87% and 87.17%, respectively. Minimum detectable differences (△) at α=0.05 and 1-β=0.8 were less than 20% (e.g., 15.58% and 19.16% AUC_t and C_(max), respectively). The 90% confidence intervals were within ±20% (e.g., -11.84∼6.41 and -10.57∼11.88 for AUC_t and C_(max), respectively). Two parameters met the criteria of KFDA for bioequivalence, indicating that Neurocetil^(TM) tablet is bioequivalent to Nicetile^(TM) tablet.

카두라 정(독사조신 2mg)에 대한 카르딜 정의 생물학적 동등성

조혜영,김수진,심영순,임동구,오인준,문재동,이용복 전남대학교 약품개발연구소 2000 약품개발연구지 Vol.9 No.1

Doxazosin, a postsynaptic selective α1-adrenoceptor antagonist, is a potent antihypertensive agent which reduces peripheral resistance and blood pressure by vasodilatation of peripheral vessels. It is also used in the treatment of urinary obstruction by benign prostatic hypertrophy. The purpose of the present study was to evaluate the bioaquivalence of two doxazosin tablet. Cardura^(TM) (Pfizer Korea Ltd.) and Cardil^(TM) (Kyongdong Pharmaceutical Co., Ltd), according to the guidelines of Korea Food and Drug Administration (KFDA). Sixteen normal male volunteers, 24.19±2.48 years in age and 62.41±6.66 ㎏ in body weight, were divided into two groups and a randomized 2×2 cross-over study was employed. After were tablet containing 2 ㎎ of doxazosin was orally administered, blood was taken at predetermined time intervals and the concentrations of doxazosin in serum were determined with an HPLC method using spectrofluorometric detector. 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. The results showed that the differences in AUC_t, C_(max) and T_(max) between two tablets were -1.54%, -1.51% and 3.42%, respectively, when calculated against the Cardura^(TM) tablet. The powers (1-β) for AUC_t, C_(max) and T_(max) were all more than 99.00%. Minimum detectable differences (Δ) at α=0.05 and 1-β=0.8 were all less than 20% (e.g., 12.73%, 12.84% and 13.01% for AUC_t, C_(max) and T_(max) respectively). The 90% confidence intervals were all within ±20% (e.g., -8.97∼5.90, -9.01∼6.00 and -4.16∼11.05 for AUC_t, C_(max) and T_(max) respectively). All of the above pare- meters met the criteria of KFDA for bioequivalence, indicating that Cardil^(TM) tablet is bioequivalent to Cardura^(TM) tablet.

클래리시드 정(클래리스로마이신 250mg)에 대한 터비나 정의 생물학적 동등성

조혜영,김수진,심영순,임동구,오인준,이용복,문재동 전남대학교 약품개발연구소 2000 약품개발연구지 Vol.9 No.1

The bioequivalence of two clarithromycin tablets, the Klaricid^(TM) (Ciba-Geigy Korea Ltd.) and tire Pylocin^(TM) (Kyungdong Pharmaceutical Co., Ltd.), was evaluated according to the Korean Guidelines for Bioequivalence Test (KGBT 1998). Sixteen healthy male volunteers (20-26 years old) were randomly divided into two groups and a randomized 2×2 cross-over study was employed After one tablet containing 250 ㎎ of clarithromycin was orally administered, blood sample was taken at predetermined time intervals, and the concentrations of clarithromycin in serum were determined using high-performance liquid chromatographic method with electrochemical detector The pharmacokinestic parameters (area under the concentration-time curve; AUC_t maximum concentration; C_(max) and time to maximum concentration; T_(max)) were calculated and analysis of variance (ANOVA) was utilized for the statistical analysis of parameters. The results showed that the differences in AUC_t, C_(max) and T_(max) between two tablets based on Klaricid^(TM) tablet were -0.22%, -0.48% and -1.63%, respectively. The powers (1-β) for AUC_t, C_(max) and T_(max) were 99.07%, 88.15% and 99.99%, respectively. Detectable differences (A) and 90% confidence intervals (α=0.10) were all less than ±20%. All the parameters above met the criteria of KGBT 1998, indicating that Pylocin^(TM) tablet is bioequivalent to Klaricid^(TM) tablet.

조프란 정(온단세트론 8mg)에 대한 하나 온난세트론 정의 생물학적 동등성

조혜영,김수진,심영순,임동구,오인준,문재동,이용복 전남대학교 약품개발연구소 2000 약품개발연구지 Vol.9 No.1

Ondansetron is a potent, highly selective 5-hydroxytryptamine3(5-HT3) receptor- antagonist, for the management of nausea and vomiting induced by cytotoxic chemotherapy and radiography. and the treatment of post-operative nausea and vomiting. The purpose of the present study was to evaluate the bioequivalence of two ondansetron tablets. Zofran^(TM), (Glaxo Wellcome Korea Ltd.) and Hana ondansetron (Hang Pharmaceutical Co., Ltd.), according to the guidelines of Korea Food and Drug Administration (KFDA). Eighteen normal male volunteers. 23.56±1.79 year in age and 67.35±8.35 ㎏ in body weight, were divided into two groups and a randomized 2×2 cross-over study was employed. After one tablet containing 8 ㎎ of ondansetron was orally administered, blood was taken at predetermined time intervals and the concentrations of ondansetron in serum were determined using HPLC with UV detector. 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. The results showed that the differences in AUC_t, C_(max) and T_(max) between two tablets were 7.53%, -0.23% and -3.92%, respectively when calculated against the Zofran^(TM), tablet. The powers (1-β) for AUC_t, C_(max) and T_(max) were above 99.00%, above 99.00% and 84.99%, respectively. Minimum detectable differences (Δ) at α=0.1 and 1-β=0.8 were all less than 20% (e.g., 12.25%, 10.88% and 18.37% for AUC_t, C_(max) and T_(max) respectively). The 90% confidence intervals were all within ±20% (e.g., -0.70∼15.76, -7.53∼7.08 and -16.27∼8.42 for AUC_t C_(max) and T_(max), respectively). All of the above parameters met the criteria of KFDA for bioequivalence, indicating that Hana ondansetron tablet is bioequivalent to Zofran^(TM), tablet.

라미실 정(테르비나편 125mg)에 대한 터비나 정의 생물학적 동등성

김수진,정인성,조혜영,심영순,정태진,오인준,문재동,이용복 전남대학교 약품개발연구소 2000 약품개발연구지 Vol.9 No.1

Terbinafine is an orally active antifungal agent as it inhibits the fungal enzyme squalene epoxidase, which is important in the early biosynthetic pathway of ergosterol. This leads to abnormal development of the fungal cell membrane. Bioequivalence of two terbinafine tablets. Lamisil^(TM) (Novartis Korea Ltd.) and Terbina^(TM) (Korean Drug Co., Ltd.), was evaluated according to the guidelines of Korea Food and Drug Administration (KFDA). Sixteen normal male volunteers, 23.56±1.75 years old and 65.60±8.54 ㎏ of body weight, were divided into two groups and a randomized 2×2 cross-over study was employed. After one tablet containing 125 ㎎ of terbinafine was orally administered, blood was taken at predetermined tune intervals and the serum concentrations of terbinafine were determined using an HPLC method with UV detector The pharmacokinetic parameters (AUC_t, C_(max) and T_(max)) were calculated and ANOVA test was utilized for the statistical analysis of parameters. The results showed that the differences in AUC_t, C_(max) and T_(max) between two tablets based on Lamisil^(TM), tablet watt -2.53%, -2.98% and 8.13%, respectively. The powers (1-β) for AUC_t, C_(max) and T_(max) were 85.21%, 98.21% and 93.11%, respectively. Minimum detectable differences (Δ) at α=0.1 and 1-β=0.8 were all less than 20%. The 90% confidence intervals were all within ±20%. All the parameters above test the criteria of KFDA for bioequivalence, indicating that Terbina^(TM) tablet is bioequivalent to Lamisil^(TM) tablet.

디스그렌 캅셀(트리플루살 300 mg)에 대한 키그린 캅셀의 생물학적 동등성

김수진,이용복,임동구,문재동,심영순,손선미 한국약제학회 1999 Journal of Pharmaceutical Investigation Vol.29 No.4

Triflusal is a new antithrombotic agent which inhibits both platelet cyclooxygenase and c-AMP phosphodiesterase activity. The purpose of the present study was to evaluate the bioequivalence of two triflusal capsules, Disgren^(TM) (Myung-In Pharmaceutical Co., Ltd.) and Tigrin^(TM) (Hana Pharmaceutical Co., Ltd.) according to the guidelines of Korea Food and Drug Administration (KFDA). Eighteen normal male volunteers, 22.94±1.83 in age and 63.71±10.43 ㎏ in body weight, were divided into two groups and a randomized 2×2 cross-over study was employed. After one capsule containing 300 ㎎ of triflusal was orally administered, blood was taken at predetermined time intervals and the concentrations of triflusal in serum were determined using HPLC method with UV detector. 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. The results showed that the differences in AUC_t, C_(max) and T_(max) between two capsules were -0.30%, 0.81% and -3.03%, respectively when calculated against the Disgren^(TM) capsule: The powers (1-β) for AUC_t, C_(max) and T_(max) were 98.29%, 84.73% and 81.02%, respectively. Minimum detectable differences (Δ) at α=0.l and 1-β=0.8 were all less than 20% (e.g., 12.91 %, 18.46% and 19.65% for AUC_t; C_(max) and T_(max), respectively). The 90% confidence intervals were all within ±20%(e.g., -8.97∼8.37, -11.58∼13.22 and -16.23∼10.17 for AUC_t, C_(max) and T_(max), respectively). All of the above parameters (1-β, Δ and 90% confidence intervals) met the criteria of KFDA for bioequivalence, indicating that Tigrin^(TM) capsule is bioequivalent to Disgren^(TM) capsule.