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리스페달 정(리스페리돈 2㎎)에 대한 리스펜 정의 생물학적 동등성
조혜영,박은자,강현아,백승희,이석,박찬호,문재동,이용복 한국약제학회 2004 Journal of Pharmaceutical Investigation Vol.34 No.2
The purpose of the present study was to evaluate the bioequivalence of two risperidone tablets, Risperdal (Janssen Korea Co., Ltd) and Rispen (Myung In Pharm. Co., Ltd), according to the guidelines of Korea Food and Drug Administration (KFDA). The risperione release from the two risperidone formulations in vitro was tested using KP Ⅷ Apparatus Ⅱ method with various of dissolution media (pH 1.2, 4.0, 6.8 butter solution and water). Twenty four healthy male subjects, 23.33±2.10 years in age and 69.24±8.05 kg in body weight, were divided into two groups and a randomized 2×2 crossover study was employed. After one tablet containing 2 ㎎ as risperidone was orally administered, blood was taken at predetermined time intervals and the concentration of risperidone in serum were determined using HPLC method with UV detector. The dissolution profiles of two formulations were similar at all dissolution media. Besides, the pharmacokinetic parameters such as AUC_(t), C_(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 Risperdal were 0.20, -1.29 and -11.09% 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(0.90)∼log(1.03) and log(0.84)∼log(1.09) for AUC_(t) and C_(max), respectively). Thus, the criteria of the KFDA guideline for the bioequivalence were satisfied, indicating Rispen tablet and Risperdal tablet were bioequivalent.
무코스타 정(레바미피드 100 mg) 에 대한 레바미드 정의 생물학적 동등성
조혜영,정현철,오인준,문재동,이용복 전남대학교 약품개발연구소 2001 약품개발연구지 Vol.10 No.-
Rebamipide is a novel anti-gastric ulcer agent that has been reported to increase the synthesis of mucus. to increase the mucosal concentration of prostaglandin, and to promote rapid ulcer healing. The purpose of the present study was to evaluate the bioequivalence of two rebamipide tablets, Mucosta^TM (Otsuka Korea Pharmaceutical Co., Ltd.) and Rebamide^TM (Kyung Dong Pharmaceutical Co., Ltd.), according to the guidelines of Korea Food and Drug Administration (KFDA). The rebamipide release from the two rebamipide tablets in vitro was tested using KP Ⅶ Apparatus Ⅱ method at pH 6.8 dissolution media. Twenty normal male volunteers, 24.20±2.26 years in age and 66.19±9.41㎏ in body weight, were divided into two groups and a randomized 2×2 cross-over study was employed. After one tablet containing 100㎎ of rebamipide was orally administered, blood was taken at predetermined time intervals and the concentrations of rebamipide in serum were determined using HPLC method with fluorescence detector. The dissolution profiles of two rebamipide tablets were very similar at pH 6.8 dissolution media. Besides, 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. The results showed that the differences in AUC_t, C_max and T_max between two tablets based on the Mucosta^TM were -2.57%, 5.77% and - 1.47%, respectively. Minimum detectable differences (Δ) at α=0.05 and 1-β=0.8 were less than 20% (e.g., 12.62% and 17.63% for AUC_t and C_max, respectively). The powers (1-β) at α=0.05, Δ=0.2 for AUC_t and C_max. were above 99.00% and 88.56%, respectively. The 90% confidence intervals were within ±20% (e.g., -9.96~4.82 and -4.54~16.09 for AUC_t and C_max respectively). Two parameters met the criteria of KFDA for bioequivalence, indicating that Rebamide^TM tablet is bioequivalent to Mucosta^TM tablet.
구개열에서 비인두강의 생리해부학적 구조와 과비음과의 연관성 연구
조준희,표화영,최홍식,최병재,손흥규,심현섭 大韓小兒齒科學會 2004 大韓小兒齒科學會誌 Vol.31 No.4
비인강폐쇄란 연구개, 인두측벽 그리고 인두후벽간의 움직임이 서로 조화되어 구강과 비강을 나누어주는 괄약근 기전으로서 연하, 호흡, 발음 등의 생리적기능에 중요한 역할을 한다. 이 기능에 문제가 생긴 경우를 비인강폐쇄부전이라하며 그 원인으로는 (1) 연구개의 길이 및 움직임이상 (2) 비인두강의 해부학적 공간문제 (3) 인두 후벽과 측벽의 기능이상 등이 있다. 본 연구는 구개열 환자의 측면두부방사선계측사진을 통해 비인두강을 생리해부학적으로 분석하였으며 산출된 말소리의 과비음정도를 Nasometer로 평가하였다. 이로부터 얻은 정상군과 구개열환자군의 결과를 각각 비교하였으며, 비인강폐쇄부전과의 연관성을 알아보기 위하여 Anatomic VPI와 Nasalance score의 값을 비교분석하였다. 얻어진 결과는 다음과 같았다. 1. 측면두부방사선계측사진 결과, 연구개 길이, 연구개 두께, 비인강 깊이, 비인강 면적, Adequate ratio에서 두 그룹간 유의한 차이를 나타내었다. 2. Nasometer 결과. 모음/오/와 구강공명음문장, 구강장해음문장에서 두 그룹 간 유의한 차이를 나타내었다. 3. 구개열환자군에서 비인두강의 폐쇄부전 정도를 표현해주는 Anatomic VPI와 Nasalance score는 전반적으로 연관성이 없었다. 다만, 모음/이/와 일부 구강자음으로 이루어진 문장에서 다소의 상관성을 나타내었다. 결론적으로, 측면두부방사선계측사진과 Nasometer 각각의 검사결과에서 두 그룹간 유의한 차이를 찾아볼 수 있었으나, 구개열환자군내에서 비인강폐쇄부전을 표현하는 Anatomic VPI와 Nasalance score는 모음/이/와 구강자음을 포함한 문장을 제외하고는 전반적으로 연관성이 없었다. Velopharyngeal closure is a sphincter mechanism between the activities of the soft palate, lateral pharyngeal wall and the posterior pharyngeal wall, which divides the oral and nasal cavity. It participates in physiological activities such as swallowing, breathing and speech. It is called a velopharyngeal dysfunction when this mechanism malfunctions. The causes of this dysfunction are defects in (1) length, function, posture of the soft palate, (2) depth and width of the nasopharynx and (3) activity of the posterior and lateral pharyngeal wall. The purposes of this study are to analyze the nasopharynx of cleft palate patients using cephalometry and to evaluate the degree of hypernasality using nasometry to find its relationship with velopharyngeal dysfunction. The following results were obtained : 1. In cephalometry, there were significant differences in soft palate length, soft palate thickness, nasopharyngeal depth, nasopharyngeal area, and adequate ratio between two groups. 2. In nasometry, there were significant differences between two groups in vowel /o/ and sentences including oral consonants. 3. In cleft palate patients, though no general correlation was found between Anatomic VPI and nasalance scores, vowel /i/ and sentences including oral consonants were slightly correlated. In conclusion, cephalometry and nasometer results were significantly different between the two groups. Though in the cleft palate group. Anatomic VPI and nasalance scores, which are indices for velopharyngeal closure, excluding the vowel /i/ and sentences including oral consonants show generally no significance.
리마틸 정(부시라민 100 mg)에 대한 부시린 정의 생물학적 동등성
조혜영,이문석,오인준,김동현,문재동,이용복 전남대학교 약품개발연구소 2001 약품개발연구지 Vol.10 No.-
Bucillamine is a novel cysteine derivative with two free intramolecular sulfhydryl groups, and has a preventive and therapeutic effect on adjuvant arthritis, suggesting its antirheumatic action. With respect to the effect on the immune system, bucillamine-exerted such immunoregulating actions are to nomalize an excessive reduction or acceleration in immune reaction. It is useful not only in patients with early stage of rheumatoid arthritis (RA) but also in those with active RA retained for more than 10 years. The purpose of the present study was to evaluate the bioequivalence of two bucillamine tablets, Rimatil^TM (Chong Kun Dang Pharmaceutical Co., Ltd.) and Bucilin^TM (Kuhn Il Pharmaceutical Co., Ltd.), according to the guidelines of Korea Food and Drug Administration (KFDA). Eighteen normal male volunteers. 23.67±2.09 years in age and 65.03±6.73㎏ in body weight, were divided into two groups and a randomized 2×2 cross-over study was employed. After three tablets containing 100㎎ of bucillamine per tablet were orally administered, blood was taken at predetermined time intervals and the concentrations of bucillamine in serum were determined using GC/MS with mass selective 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_mex and T_max between two tablets were -0.29%, -3.20% and 8.22%, respectively, when calculated against the Rimatil^TM tablet. The powers (1-β) for AUC_t and C_max were 84.31% and 91.16%, respectively. Minimum detectable differences (Δ) at α=0.10 and 1-β=0.8 were less than 20% (e.g., 18.58% and 16.51% for AUC_t and C_max, respectively). The 90% confidence intervals were within ±20% (e.g., -12.77∼12.20 for AUC_t and -14.30∼7.90 for C_max). Two parameters met the criteria of KFDA for bioequivalence, indicating that Bucilin^TM tablet is bioequivalent to Rimatil^TM tablet.
레보프라이드 정(레보설피리드 25㎎)에 대한 레보피드 정의 생물학적 동등성
조혜영,강현아,문재동,이용복 한국약제학회 2002 Journal of Pharmaceutical Investigation Vol.32 No.2
Levosulpiride is the levo-enantiomer form of racemic sulpiride, a benzamide derivative selectively inhibiting dopaminergic D_2 receptors at the trigger zone both in the central nervous system and in the gastrointestinal tract. The purpose of the present study was to evaluate the bioequivalence of two levosulpiride tablets, Levopride (SK Pharmaceutical Co., Ltd.) and Levopid (Dae Won Pharmaceutical Co., Ltd.), according to the guidelines of Korea Food and Drug Administration (KFDA). The levosulpiride release from the two levosulpiride tablets in vitro was tested using KP VII Apparatus Ⅱ method with various different kinds of dissolution media (pH 1.2, 4.0, 6.8 buffer solution and water). Twenty eight normal male volunteers, 23.82±3.26 years in age and 69.13±8.58 kg in body weight, were divided into two groups and a randomized 2×2 cross-over study was employed. After one tablet containing 25 mg of levosulpiride was orally administered, blood was taken at predetermined time intervals and the concentrations of levosulpiride in serum were determined using HPLC method with fluorescence detector. The dissolution profiles of two levosulpiride tablets were very similar at all dissolution media. Besides, 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 and C_max and untransformed T_max. The results showed that the differences in AUC_t, C_max and T_max between two tablets based on the Levopride were -1.17%, 1.20% and -1.09%, respectively. There were no sequence effects between two tablets 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(0.93)∼log(1.07) and log(0.90)∼log(1.14) for AUC_t and C_max, respectively). The 90% confidence interval using untransformed data was within ±20% (e.g., -19.47∼16.20 for T_max). All parameters met the criteria of KFDA guideline for bioequivalence, indicating that Levopid tablet is bioequivalent to Levopride tablet.
스프렌딜 지속정(펠로디핀 5㎎)에 대한 스타핀 지속정의 생물학적동등성
조혜영,강현아,이석,백승희,박은자,최후균,문재동,이용복 한국약제학회 2003 Journal of Pharmaceutical Investigation Vol.33 No.4
Felodipine is a calcium antagonist that lowers blood pressure by reducing peripheral resistance by means of a direct, selective action on smooth muscle in arterial resistance vessels. Furthermore, it have been approved for the effective in angina pectoris and cardiac failure. The purpose of the present study was to evaluate the bioequivalence of two felodipine extended release (ER) tablets, Splendil (YuHan Corporation) and Stapin (Hana Pharmaceutical Co., Ltd.), according to the guidelines of Korea Food and Drug Administration (KFDA). THe felodipine release from the two felodipine formulations in vitro was tested using KP Ⅷ Apparatus Ⅱ method at pH 6.5 buffer solution. Twenty six healthy male subjects, 22.73±1.78 years in age and 66.66±7.28 ㎏ in body weight, were divided into two groups and a randomized 2×2 cross-over study was employed. After two tablets containing 5 ㎎ as felodipine were orally administered, blood sample was taken at predetermined time intervals and the concentrations of felodipine in serum were determined using column-switching HPLC method with UV detector. The dissolution profiles of two formulations were similar at pH 6.5 buffer solution. Besides, the pharmacokinetic parameters such as AUG_(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) and C_(max) and untransformed T_(max). The results showed that the differences between two formulations based on the Splendil were 2.53%, 1.32% and 18.32% for AUC_(t), C_(max) and T_(mzx), 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(0.86)∼log(1.20) and long(0.89)∼long(1.23) for AUC_(t) and C_(max), respectively). Thus, the criteria of the KFDA guidelines for the bioequivalence was satisfied, indicating Stapin ER tablet and Splendil ER tablet are bioequivalent.
그란닥신 정(토피소팜 50 mg)에 대한 토핌 정의 생물학적 동등성
조혜영,정현철,허수희,임동구,문재동,이용복 전남대학교 약품개발연구소 2001 약품개발연구지 Vol.10 No.-
Tofisopam is a new type of tranquilizer valuable for the relief of anxiety and tension in a wide range of emotional disorders. Tofisopam has the therapeutic characteristics of a minor tranquilzer and a mild stimulatory effect. The purpose of the present study was to evaluate the bioequivalence of two tofisopam tablets, Grandaxin^TM (Hwan In Pharmaceutical Co., Ltd.) and Tofim^TM (Kyung Dong Pharmaceutical Co., Ltd.), according to the guidelines of Korea Food and Drug Administration (KFDA). Eighteen normal male volunteers, 23.11±2.83 years in age and 65.43±7.64㎏ in body weight, were divided into two groups and a randomized 2 x 2 cross-over study was employed. After one tablet containing 50㎎ of tofisopam was orally administered, blood was taken at predetermined time intervals and the concentrations of tofisopam in serum were determined using HPLC method with UV detector. 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. The results showed that the differences in AUC_t, C_max and T_max between two tablets based on the Grandaxin^TM were -5.59%, 2.22% and -13.18%, respectively. Minimum detectable differences (Δ) at α=0.10 and 1-β=0.8 were less than 20% (e.g., 14.95% and 19.34% for AUC_t and C_max, respectively). The powers (1-β) at α=0.10, Δ=0.2 for AUC_t and C_max were 95.21% and 81.93%, respectively. The 90% confidence intervals were within ±20% (e.g., -15.64∼4.45 and -10.77∼-15.21 for AUC_t, and C_max, respectively). Two parameters met the criteria of KFDA for bioequivalence, indicating that Tofim^TM tablet is bioequivalent to Grandaxin^TM tablet.
그란닥신 정(토피소팜 50mg)에 대한 토핌 정의 생물학적 동등성
조혜영,정현철,허수희,임동구,문재동,이용복 한국약제학회 2001 Journal of Pharmaceutical Investigation Vol.31 No.2
Tofisopam is a new type of tranquilizer valuable for the relief of anxiety and tension in a wide range of emotional disorders. Tofisopam has the therapeutic characteristics of a minor tranquilzer and a mild stimulatory effect. The purpose of the present study was to evaluate the bioequivalence of two tofisopam tablets, Grandaxin^TM (Hwan In Pharmaceutical Co., Ltd.) and Tofim^TM (Kyung Dong Pharmaceutical Co., Ltd.), according to the guidelines of Korea Food and Drug Administration (KFDA). Eighteen normal male volunteers, 23.11±2.83 years in age and 65.43±7.64 kg in body weight, were divided into two groups and a randomized 2×2 cross-over study was employed. After one tablet containing 50 mg of tofisopam was orally administered, blood was taken at predetermined time intervals and the concentrations of tofisopam in serum were determined using HPLC method with UV detector. 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. The results showed that the differences in AUC_t C_max and T_max between two tablets based on the Grandaxin^TM were -5.59%, 2.22% and -13.18%, respectively. Minimum detectable differences (Δ) at α=0.10 and 1-β=0.8 were less than 20% (e.g., 14.95% and 19.34% for AUC_t and C_max respectively). The powers (1-β) at α=0.10, Δ=0.2 for AUC_t and C_max were 95.21% and 81.93%, respectively. The 90% confidence intervals were within ±20% (e.g., -15.64∼4.45 and -10.77∼15.21 for AUC_t and C_max respectively). Two parameters met the criteria of KFDA for bioequivalence, indicating that Tofim^TM tablet is bioequivalent to Grandaxin^TM tablet.
아마릴 정(글리메피리드 2㎎)에 대한 글리메드 정의 생물학적 동등성
조혜영,박은자,강현아,백승희,이석,김세미,문재동,이용복 한국약제학회 2004 Journal of Pharmaceutical Investigation Vol.34 No.2
The purpose of the present study was to evaluate the bioequivalence of two glimepiride tables, Amaryl^(?)(Handok/Aventis Pharm. Co., Ltd.) and Glimed (Kuhn Ⅱ Pharm. Co., Ltd.), according to the guidelines of Korea Food and Drug Administration (KFDA). The glimepiride release from the two glimepiride formulations in vitro was tested using KP Ⅷ Apparatus Ⅱ method with a variety of dissolution media (pH 1.2, 4.0, 6.8 buffer solution, water and blend of PSB 80 into each dissolution medium). Twenty six healthy male subjects, 22.65±2.19 years in age and 66.55±8.85 kg in body weight, were divided into two groups and randomized 2×2 cross-over study was employed. After one tablet containing 2 ㎎ as glimepiride was orally administered, blood was taken at predetermined time intervals and the concentrations of glimepiride in serum were determined using HPLC method with UV detctor. The dissolution profiles of two formulations were similar at all dissolution media. Besides, the pharmacokinetic parameters such as AUC_(t), C_(max) and untransformed T_(max). The results showed that the differences between two formulations based on the Amaryl were -3.70, -8.28 and 0.61% 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(0.84)∼log(1.04) and log(0.82)∼log(1.03) for AUC_(t) and C_(max), respectively). Thus, the criteria of the KFDA guideline for the bioequivalence were satisfied, indicating Glimed tablet and Amaryl tablet were bioequivalent.