정상 성인에 경구 투여한 Cefixime 두 정제의 생물학적 동등성 비교

강진양,서성훈,이경태,문창훈,강진한,이동건,최정현,신완식 대한화학요법학회 2000 대한화학요법학회지 Vol.18 No.4

목적 : 식품의약안전청 고시 제 1998-86호(1998. 8.26) "생물학적 동등성 시험 기준"에 의하여 섹심 캅셀(시험약, 한국유나이트제약)과 슈프락스 캅셀(대조약, 동아제약)의 생물학적 동등성을 비교 검토하였다. 방법 : 2×2 라틴 방격법에 따라 건강한 성인 남성 지원자 20명에게 cefixime 100㎎씩 경구투여하였다. 약제투여 후 12시간까지 일정간격으로 채혈하였고 각 피험자들의 혈중약물농도 데이터로부터 구한 Area under the concentration (AUC), C_(max), T_(max) 등의 생체이용률 파라미터에 대해 통계학적으로 고찰하여 두 제제간의 생물학적 동등성을 평가하였다. 결과 : AUC, C_(max), T_(max)에 대한 평균값의 차가 각각 1.26%, 3.73%, 6.21%로서 모두 대조약의 20% 이내에 들어 생물학적 동등성 판정기준의 전제조건을 만족하였다. 분산분석 결과 AUC, C_(max), T_(max)의 각 비교 항목에 있어서 모두 유의수준 α=0.05의 군/순서효과 검정에서 F비가 F 분석표의 한계값보다 작아 교차시험이 제대로 이루어졌음을 확인할 수 있었으며, AUC, C_(max), T_(max) 각 비교항목에 있어서 유의수준 α=0.05에서 대조약에 대한 최소검출차(Δ)가 각각 17.74%, 17.05%, 15.67%로 모두 20% 이내이었으며, 검출력(1-β)도 모두 0.8 이상으로 나타나 생물학적 동등성 판정기준을 만족시켰다. 또 AUC, C_(max), T_(max) 각 비교항목에 있어서 대조약에 대한 생체이용률 차이의 신뢰한계(δ)가 ±20% 이내이어야 한다는 생물학적 동등성 판정기준을 모두 만족시켰다. 결론 : 이상의 실험결과로 시험약은 대조약에 대하여 생물학적 동등성 평가항목인 AUC, C_(max), T_(max)에서 모두 판정기준을 만족시켜 시험약은 대조약과 생물학적으로 동등하다고 사료된다. Background : The study was designed to compare the bioeqivalence between the test (CEXIME®. United Korea. Co., Ltd) and control (SUPRAX®. Dong-a Pharm. Co.. Ltd) capsules of cefixime. Methods : Twenty. healthy, male volunteers completed the study Each subject ingested single dose (100 ㎍) of the control and test drugs in 2?2 crossover design with a week drug-free interval between the doses. Blood samples were collected serially up to 12 hours and plasma concentrations of cefixime were measured by high-performance liquid chromatography with UV detection. A non-compartmental approach was used for analysis of the concentration-time data. Results : The area under the curve (AUC), the maximum concentration of drug (C_(max)). and time to reach C_(max)(T_(max)) did not show any significant difference between the two preparations by ANOVA. The mean differences of AUC, C_(max), and T_(max) were within 20% of the control drug, those were 1.26%. 3.73%. and 6.21%. respectively. The confidence limits of three parameters were satisfied the bioeqivalence criteria. Conclusion : These results suggest that the test drug was bioequivalent with the control drug.

관해유도 항암요법을 받는 백혈병 환자에서 진균 감염증의 예방 : 무작위 배정법과 이중 눈가림법에 의한 Fluconazole과 Nystain의 효과에 관한 다기관 공동연구 A Randomized, Double-blind, Multicenter Trial to Compare Fluconazole with Nystatin

최강원,오명돈,배현주,백경란,박선양,김병국,신완식,강문원,진종률,박종원,김춘추,김동집,한지숙,민유홍,이선주,고윤웅 대한화학요법학회 1993 대한화학요법학회지 Vol.11 No.2

Fluconazole의 진균 감염증 예방 효과와 안전성에 관하여 3개 대학병원에서 관해유도화학요법을 받는 급성 백혈병환자를 대상으로 무작위 배정법과 너도나도 누가림법에 의하여 연구하였다. 모두 62명의 환자에게 fluconazole(100㎎ bid) 또는 nystatin(1,000,000IU/day)을 무작위로 투여하였다. 투약은 관해유도화학요법과 같은 날짜에 시작하여 호중구수가 1,000㎣이상으로 회복되거나 진균 감염증이 확인되거나 의심되어 Amphotericin-B를 시작하거나, 약과 관련된 부작용이 나타날 때까지 계속하였다. 진균 colonization은 fluconazole군에서 감소하였으나 nystqatin군에서는 증가하였다, 표재성 진균감염증으로 nystatin군에서 C. albicans 진균혈증 1례와 C.parasilosis 진균혈중 1례가 발생하였다. 경험적 항진균요법으로 Amphotericin-B를 투여한 경우는 fluconazolerns 34명중 7례(21%), nystatinrns 28명중 10례(36%)였다(p<0.05). Fluconazole군과 nystatin군 사이에 부작용이나 사망률에 차이는 없었다. 결론적으로, fluconazole은 관해유도화학요법을 받는 급성 백혈병환자에서 진균의 colonization을 줄이는데 효과적이고 안전한 항진균제이다. We made a randomized, double-blind, multicenter trial to compare the efficacy and safety of fluconazole with nystatin for prevention of fungal infections in patients with acute leukemia. Sixty-two adult undergoing remission induction chemotherapy for cute leukemia were enrolled. Patients were randomly assigned to receive either fluconazole (100㎎ bid) or nystatin(1,000,000IU×6/day) with corresponding placebo. The study drug was started in initiation of chemotherapy and continued until recovery of neutrophil counts(>1,000/㎣), development of proven or suspected invasive fungal infection, or the occurrence of drug-related toxicity. Fungal colonization decreased in fluconazole(F) group, however increased in nystain(n) group. Superficial fungal infection occurred in 1 of 34 F group, whereas invasive fungal infection developed in 3 of 28 N group. Empirical amphotericin-B therapy was given in 7 of 34(21%) F group and 10 of 28(36%) N group(p>0.05). The incidence of drug-related side effects and overall moratlity were similar in both study groups.

Slim Patch Type을 이용한 카페인의 경피흡수에 관한 연구

김정수,권동환,임도형,김구서,강진양 한국약제학회 2006 Journal of Pharmaceutical Investigation Vol.36 No.2

The Case-Control Studies Between The Single Nucleotide Polymorphisms of the Human SA and MTHFR Gene and Hypertension in Korean Population

Kang, Byung-Yong,Bae, Joon-Seol,Kim, Ki-Tae,Lee, Kang-Oh,Kang, Chin-Yang,Chung, Ki-Wa,Oh, Sang-Duk Korean Environmental Mutagen Society 2002 한국환경성돌연변이·발암원학회지 Vol.22 No.3

The role of the kidney in initiating hypertension has been much debated. The SA gene is expressed in the kidney and is association with hypertension in man and in experimental animal models. Also, increased plasma concentrations of homocysteine have been found in patients with coronary artery disease (CAD) and hypertension. The genetic variation of methlene tetrahydrofolate reductase (MTHFR) gene is related to its enzyme activity and to the plasma homocysteine concentration. In view of the effect of SA and MTHFR as risk factor for cardiovascular diseases, we investigated the Pst I RFLP of the SA gene and C667T mutation of the MTHFR gene in the Korean patients with hypertension. There were no significant differences in the allele and genotype frequencies of these polymorphisms between normotensive and hypertensive subjects. Therefore, our results do not support a possible role of these genes on hypertension in Korean population.

Association Study Between Genetic Polymorph isms in Interleukin-1 Gene Family and Adult Periodontitis in Korean

Kang, ByungYong,Kang, Chin Yang,Lee, Kang Oh Korean Society of ToxicologyKorea Environmental Mu 2004 Toxicological Research Vol.20 No.4

Adult periodontitis (AP) is a chronic inflammatory disease whose etiology is not well defined. Some studies suggested that the clinical characteristics of this disease may be in part explained by genetic factors, and some attempts to find genetic markers for this disease were successful. The interleukin-1 (IL-1) gene family as one of genetic factors may influence the expression of adult periodontitis. The aim of present study is to investigate the frequencies of genetic polymorphisms in the IL-1 gene family encoding three genes (IL-1A, IL-1B and IL-1RN) in Korean AP patients and periodontically healthy controls. There were no significant differences in genotype and allele frequencies of these polymorph isms between two groups, respectively. However, -511 polymorphism of IL-1 B gene was significantly associated with mean pocket depth (MPD, mm) value in AP patients (P<0.05). Therefore, our results suggest that -511 polymorphism in the IL-1B gene may be useful as a genetic marker for the severity of AP in Koreans.

Muscle-Specific Creatine Kinase Gene Polymorphisms in Korean Elite Athletes

Kang, Byung-Yong,Kang, Chin-Yang,Lee, Kang-Oh Korean Society of ToxicologyKorea Environmental Mu 2003 Toxicological Research Vol.19 No.2

In view of the importance of muscle-specific creatine kinase (CKMM) gene as a genetic factor for athletic performance, we investigate the relationship between elite athletic performance and two restriction fragment length polymorphisms (Ncol and Taql RFLPs) in the CKMM gene. Genomic DNA was extracted from white blood cells of 98 unrelated male Korean elite athletes and 04 sedentary controls, respectively. Two genetic polymorphisms in the CKMM gene were detected by the polymerase chain reaction and the digestion with restriction endonucleases, Ncol and Taql, respectively. There were no significant associations between two genetic polymorphisms in the CKMM gene and elite athletic performance or clinical parameters in our subjects. Therefore, these findings suggest that two genetic polymorphisms in the CKMM gene may not be useful as genetic markers to predict the athletic performance in male Koreans.

The Mitochondrial DNA 5178 A/C Polymorphism in Elite Korean Male Athletes

Kang, Byung Yong,Kang, Chin Yang,Kim, Jae Hyoun,Kim, Ki Tae,Lee, Kang Oh 한국유전학회 2003 Genes & Genomics Vol.25 No.3

In view of the important role of human mitochondrial DNA (mtDNA) as a candidate for athletic performance, we investigate the mt5178 A/C polymorphism of the mtDNA in the elite Korean male athletes and sedentary male controls, Total genomic DNA was isolated from 100 elite Korean male athletes and 64 sedentary male controls. The mt 5178 A/C polymorphism was analyzed by polymerase chain reaction (PCR) and Alu I restirction fragment length polymorphism (RFLP) method. This polymorphism was not significantly associated with VO_(2max) index in elite male athletes under this study. However, the excess of A allele in marathon runners was also observed among our sporting disciplines, although no statistical significance. Further studies using larger sample size will be required to clarify the relationship between this genetic variation of mtDNA and athletic performance.

KSP and CRS Symposium on Recent Advances in Drug Dilivery and Biomaterials ( 97 , September ) : Studies on controlled release and bioavailability of piracetam by using alginate beads

(Chin Yang Kang),(Seong Joon Kwon),(Kyung Tae Lee),(Seong Hoon Seo) 경희대학교 동서약학연구소 1997 연구업적집 Vol.12 No.-

Human G-Protein ${\beta}3$ Subunit C825T Polymorphism is Associated with Serum Total Cholesterol and LDL-Cholesterol Levels in Koreans

Kang, Byung-Yong,Kang, Chin-Yang,Lee, Kang-Oh The Korean Society for Integrative Biology 2005 Integrative biosciences Vol.9 No.2

Essential hypertension results from the complex interaction between genetic and environmental factors. A C825T polymorphism of the gene encoding G-protein ${\beta}3$ subunit (GNB3), associated with enhanced G-protein coupled signaling and increased $Na^+-H^+$ exchanger, has been implicated in the development of essential hypertension in several human populations, especially in Caucasian population. We examined the disease relevance of this candidate gene by performing an association study in a study group of Korean heritage. Participants comprised 109 essential hypertensives and 109 normotensives, respectively. Genotyping was performed with PCR-BsaJI restriction digestion method. Observed genotype frequencies were in Hardy-Weinberg equilibrium in all groups. Genotype and allele frequencies did not differ significantly between normotensives and essential hypertensives (P>0.05). However, the serum total cholesterol (TC) and LDL-cholesterol levels were significantly higher in subjects with the TT genotype compared to those with the CC or CT genotypes in normotensives of our study subjects (P<0.05). Thus, these results suggest that GNB3/C825T polymorphism might be significantly associated with abnormality in serum lipid metabolism.

Association Study between the Genetic Variations of the Apo AI-CIII-AIV Gene Cluster and Hypertension among Koreans

Kang, Byung-Yong,Kang, Chin-Yang,Ki, Tae-Kim,Bae, Joon-Seol,Oh, Sang-Duk,Kim, Jae-Hyun,Lee, Kang-Oh Korean Society of ToxicologyKorea Environmental Mu 2002 Toxicological Research Vol.18 No.4

Hypertension is a multifactorial disorder in which the genetic and environmental factors are involved. In a view of the effects for hypertension as a risk factor for hypertension, we investigated the genotype and allele frequencies in the four RFLPs of the apo AI-CIII-AIV gene cluster (G to A mutation at position -75 in the apo AI promoter SstI RFLP in the ape CIII gene and HincII and HinfI RFLPs in the apo AIV gene) in the Korean patients with hypertension and normal controls. The AA genotype frequency of the G to A promoter polymorphism in hypertensives was significantly higher than that of normotensives (P < 0.05). None of the other polymorphisms showed a difference in genotype frequency between two groups. Therefore, our result suggest that the G to A promoter polymorphism of the ape AI gene may be useful as genetic marker in the ethiology of hypertension.