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262 results on '"Sang Goo Shin"'

151. Therapeutic evaluation of sustained-releasing praziquantel (SRP) for clonorchiasis: Phase 1 and 2 clinical studies

Author

Sung-Tae Hong, Sang Goo Shin, Byung Chan Chang, Jin Ho Chun, Weon Gyu Kho, Min-Ho Choi, In-Jin Jang, and Seung Jin Lee

Subjects
Adult, Male, Cure rate, Cmax, Phases of clinical research, Pharmacology, environment and public health, Praziquantel, Clinical study, Pharmacokinetics, parasitic diseases, medicine, Animals, Humans, Parasite Egg Count, Anthelmintics, Clonorchis sinensis, business.industry, Therapeutic evaluation, medicine.disease, Infectious Diseases, Area Under Curve, Delayed-Action Preparations, Clonorchiasis, Original Article, Parasitology, business, medicine.drug
Abstract

Sustained-releasing praziquantel (SRP) tablet was designed for single dose treatment regimen of clonorchiasis. A previous pre-clinical study confirmed its sustained-releasing characteristics and a better cure rate than conventional praziquantel (PZQ). In this clinical study, the pharmacokinetics of this SRP tablet were investigated in human volunteers (phase 1; 12 volunteers), and its curative efficacy was examined in clonorchiasis patients (phase 2; 20 volunteers). In the phase 1 clinical study, blood concentrations of both tablets showed wide individual variation. The AUClast of SRP was 497.9 +/- 519.0 ng * hr/ml (mean +/- SD) and PZQ of 628.6 +/- 695.5 ng * hr/ml, and the AUCinf of SRP was 776.0 +/- 538.5 ng * hr/ml and of PZQ 658.6 +/- 709.9 ng * hr/ml. Cmax values of SRP and PZQ were 90.7 +/- 82.2 ng/ml and 214.9 +/- 251.9 ng/ml, and Tmax values were 3.42 +/- 1.43 hr and 1.96 +/- 1.23 hr, respectively. SRP tablets showed similar AUC values, but lower Cmax and longer Tmax values than PZQ. In the phase 2 study, SRP at 30 mg/kg (single dose) achieved a 60% cure rate and a 95.5% egg reduction rate. The cure rate of a single dose SRP was unsatisfactory compared with that of the conventional PZQ dose, but much better than that achieved by a single dose PZQ.

Published
2006
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154. Pharmacokinetics of Rosiglitazone According to CYP2C8 Genotype in Korean Population

Author

Joo Youn Cho, S. Yi, Kyung-Sang Yu, Sang-Goo Shin, In Jin Jang, Jae Yong Chung, Hyeong Seok Lim, Kyoung Sup Hong, and You Sin Suh

Subjects
medicine.medical_specialty, Korean population, Haplotype, Biology, Endocrinology, Pharmacokinetics, Polymorphism (computer science), Internal medicine, Genotype, medicine, Pharmacology (medical), Rosiglitazone, CYP2C8, medicine.drug
Published
2005
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157. Effect of SRD5A2 genotype on pharmacodynamics of 5-alpha-reductase inhibitor analyzed by PK-PD modeling

Author

Do-Youn Oh, Hyeong-Seok Lim, In Jin Jang, Sang-Goo Shin, Jin Wook Chung, S. Yi, and Jae Youl Cho

Subjects
Pharmacology, medicine.medical_specialty, business.industry, Dutasteride, NONMEM, chemistry.chemical_compound, 5 Alpha-Reductase Inhibitor, Endocrinology, chemistry, Polymorphism (computer science), Pharmacodynamics, SRD5A2, Internal medicine, Genotype, medicine, Pharmacology (medical), business, PK/PD models
Abstract

Dihydrotesterone (DHT) converted by 5-alpha-reductase from testosterone is thought to be the androgen primarily responsible for the development of Benign Prostatic Hyperplasia. Dutasteride is a potent and specific irreversible competitive inhibitor of 5-alpha-reductase type 1 and type 2 for control of BPH. The aim of this study is to evaluate the effect of genetic polymorphism of SRD5A2 on the pharmacodynamics of dutasteride by PK-PD modeling approach. We conducted a phase I clinical study of a single oral 0.5mg dose of dutasteride in 30 healthy Korean male volunteers. We also obtained genotype of SRD5A2 V89L, coding gene of 5-alpha-reductase type 2. Data were analyzed by nonlinear mixed effect modeling using NONMEM. We used a indirect response model to explain the PK-PD characteristics. PK parameters were similar to those of other previous studies (ka = 2.79 h-1, Vd = 530 l, Cl = 10.7 lh-1). Drug concentration corresponding to 50% suppression of enzyme activity(IC50) was about 3 fold smaller in SRD5A2 V89L homomutant group(L/L) than wild type group(V/V) in PK-PD model incorporated genotype as covariate to IC50. (IC50: V/V=0.375 ng/ml, L/L=0.102 ng/ml) These findings suggest dutasteride can be more potently acting in person who have SRD5A2 V89L mutation. It is consistent with the result of in vitro inhibition study. A PK/PD modeling approach was useful to find the effect of genetic polymorphism on the PD of 5-alpha-reductase inhibitor. Clinical Pharmacology & Therapeutics (2004) 75, P12–P12; doi: 10.1016/j.clpt.2003.11.044

Published
2004
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159. Evaluation of Herb-drug Interaction in Healthy Subjects by Comparing the Cytochrome P450 Activities before and after Multiple Administrations of Herbal Medicines

Author

Dal-Seok Oh, Hocheol Kim, Kyung-Sang Yu, Jung-Ryul Kim, Sang-Goo Shin, Joo Youn Cho, Hye Ryung Chung, Jae Yong Chung, S. Yi, Hyeong Seok Lim, and In Jin Jang

Subjects
Herb-drug interactions, Traditional medicine, biology, business.industry, Healthy subjects, biology.protein, Medicine, Cytochrome P450, Pharmacology (medical), business
Published
2004
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163. Evaluation of Safety and Pharmacokinetics of Tegaserod After Multiple Oral Administrations in Healthy Korean Subjects

Author

So-Young Yi, Joo Youn Cho, Hyeong-Seok Lim, Jae-Wook Ko, Kyung-Sang Yu, Jae Yong Chung, Kyoung-Sup Hong, Sang-Goo Shin, Kyun-Seop Bae, and In-Jin Jang

Subjects
medicine.medical_specialty, Tegaserod, Pharmacokinetics, business.industry, Internal medicine, medicine, Pharmacology (medical), business, Gastroenterology, medicine.drug
Published
2003
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172. Evaluation of Safety, Tolerability and Pharmacokinetics of Lebecel (DDB-S); a Phase Ⅰ Clinical Trial

Author

Jun-Ok Moon, Hyeong-Seok Lim, So-Young Yi, In-Jin Jang, Kyung-Sang Yu, Jae Yong Chung, Kyun-Seop Bae, Sang-Goo Shin, Kyoung-Sup Hong, Lee Chi-Oh, and Joo Youn Cho

Subjects
Clinical trial, Oncology, medicine.medical_specialty, Pharmacokinetics, business.industry, Internal medicine, medicine, Phases of clinical research, Pharmacology (medical), Safety tolerability, business
Published
2001
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173. Population Pharmacokinetic-Pharmacodynamic Modeling of Captopril in Healthy Volunteers

Author

Sang-Goo Shin, So-Young Yi, Kyun-Seop Bae, Kyung Sang Yu, Joo Youn Cho, In-Jin Jang, Soon-Sung Park, and Hyeong-Seok Lim

Subjects
education.field_of_study, biology, Pharmacokinetic pharmacodynamic, business.industry, Population, Captopril, Angiotensin-converting enzyme, Pharmacology, Blood pressure, Healthy volunteers, medicine, biology.protein, Pharmacology (medical), education, business, medicine.drug
Published
2001
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174. New Drug Application Process

Author

In-Jin Jang and Sang-Goo Shin

Subjects
Clinical trial, Process management, Process (engineering), business.industry, Medicine, Pharmacology (medical), business, New drug application
Published
2001
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176. A Study on the Plasma Level of Carbamazepine and Its Epoxide in Adult Korean Patients with Epilepsy

Author

Sung-Shin Ahn, Juhan Kim, In Jin Jang, Sang-Goo Shin, Hyunwoo Nam, Dong-Seok Yim, Hyeon-Mi Park, Sang-Kun Lee, Kyung-Seok Park, and Keun-Sik Hong

Subjects
business.industry, Epoxide, Plasma levels, Carbamazepine, Pharmacology, medicine.disease, chemistry.chemical_compound, Epilepsy, chemistry, Medicine, Pharmacology (medical), business, Carbamazepine epoxide, medicine.drug
Published
2000
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177. Effect of Erythrocyte Thiopurine Methyltransferase (TPMT) Activity on Azathioprine Immunosuppression Therapy in Renal Transplant Recipients

Author

Joo Youn Cho, In-Jin Jang, Sang-Goo Shin, Curie Ahn, So-Young Yi, Jongwon Ha, Kyun-Seop Bae, Kyung Sang Yu, and Sang Joon Kim

Subjects
Thiopurine methyltransferase, biology, business.industry, medicine.medical_treatment, 6-thioguanine nucleotide, Immunosuppression, Azathioprine, Pharmacology, Renal transplant, medicine, biology.protein, Pharmacology (medical), business, medicine.drug
Published
2000
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182. Pharmacokinetics of Metoprolol in Chronic Liver Disease

Author

Kyunghoon Lee, Dong Jin Suh, In-Jin Jang, Dong-Seok Yim, Young-Ran Yoon, Jae-Gook Shin, Hee-Bok Chae, Young Sang Lee, Sang-Goo Shin, and Young-Nam Cha

Subjects
Pharmacokinetics, business.industry, Medicine, Pharmacology (medical), Pharmacology, business, Chronic liver disease, medicine.disease, Metoprolol, medicine.drug
Published
1999
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185. Population Pharmacokinetics of Vancomycin in Korean Patients

Author

Joo Youn Cho, Kyung Sang Yu, Ju-Yeun Lee, Sang-Goo Shin, Kyun-Seop Bae, Wan-Gyoon Shin, and In-Jin Jang

Subjects
medicine.medical_specialty, business.industry, Internal medicine, medicine, Vancomycin, Pharmacology (medical), Population pharmacokinetics, business, medicine.drug
Published
1998
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187. Clinical Trial of Drugs

Author

Sang Goo Shin

Subjects
Clinical trial, medicine.medical_specialty, business.industry, Internal medicine, Medicine, business
Published
1998
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190. Evaluation of Topical Agents* Anti-inflammatory Activity on Experimentally Induced Allergic Contact Dermatitis by Diphenylcyclopropenone (DPCP)

Author

Seung Hyun Moon, Hee Chul Eun, Dae Hun Suh, Sang Goo Shin, Hyunseung Lee, and In Jin Jang

Subjects
medicine.medical_specialty, medicine.drug_class, business.industry, medicine.disease, Dermatology, Anti-inflammatory, chemistry.chemical_compound, chemistry, Topical agents, medicine, Pharmacology (medical), business, Allergic contact dermatitis, Diphenylcyclopropenone
Published
1998
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194. Pharmacokinetic and Pharmacodynamic Properties of a New Long-Acting Granulocyte Colony-Stimulating Factor (HM10460A) in Healthy Volunteers.

Author

Kwang-Hee Shin, Tae-Eun Kim, Kyoung Soo Lim, Seo-Hyun Yoon, Joo-Youn Cho, Sei-Eun Kim, Kyung-Mi Park, Sang-Goo Shin, In-Jin Jang, and Kyung-Sang Yu

Subjects
COLONY-stimulating factors (Physiology), GRANULOCYTE-colony stimulating factor, GRANULOCYTES, PHARMACOKINETICS, PHARMACODYNAMICS, NEUTROPENIA, CHEMOTHERAPY complications, NEUTROPHILS
Abstract

Background HM10460A is a newly developed recombinant human granulocyte colony-stimulating factor with long-lasting characteristics. This factor is expected to be used for chemotherapy-related neutropenic conditions. Objective The aim of the present study was to evaluate the pharmacokinetics and pharmacodynamics of HM10460A following subcutaneous administration to healthy Korean subjects. Methods A randomized, double-blind, placebo-controlled, escalating single-dose study was conducted in 40 healthy Korean subjects. The subjects were allocated to single-dose groups of 5, 15, 45, 135 or 350 µg/kg, or placebo. Serial blood samples for pharmacokinetic/pharmacodynamic analyses were collected up to 22 days, and urine samples for pharmacokinetic analysis were collected up to 3 days after subcutaneous administration of HM10460A. The serum and urine concentrations were analyzed by enzyme-linked immunosorbent assay. Results Most of the serum concentrations in the 5 and 15 µg/kg dosing groups were below the lower limit of quantification (LLOQ). The median times to the peak concentration (Tmax) of HM10460A in the 45, 135, and 350 µg/kg dosing groups were 8.0, 14.0, and 24.0 h, respectively. The mean ± standard deviation values of the dose-normalized maximum concentration (Cmax) and dose-normalized area under the concentration-time curve (AUClast) for the 45, 135, and 350 µg/kg dosing groups were 14.13 ± 6.37, 66.19 ± 38.71, and 34.65 ± 19.69 µg/ L/mg, respectively, and 265.0 ± 124.1, 2144 ± 1232, and 1386 ± 701.2 µg h/L/mg, respectively. The concentrations of HM10460A in the urine were below the LLOQ in all of the subjects. In all of the dosing groups, the area under the effect-time curve (AUEClast) of both the absolute neutrophil count (ANC) and the CD34+ cell count increased as the dose increased. Conclusion HM10460A showed dose-dependent pharmacokinetic characteristics, and the systemic exposure of HM10460A was positively correlated with the ANC and CD34+ cell counts. [ABSTRACT FROM AUTHOR]

Published
2013
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