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Inhibitory Effects of 6-Gingerol on Cytochrome P450 in Human Liver Microsomes.

Journal of Korean Society for Clinical Pharmacology and Therapeutics.2011;19(1):52-58.

No abstract available.
Catechols ; Cytochrome P-450 Enzyme System ; Cytochromes ; Fatty Alcohols ; Humans ; Liver ; Microsomes, Liver

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Current Status of Clinical Research Coordinator's Employment.

Ihn Sook JEONG ; Sangmin CHOE ; Ji Hong SHON ; Won Ock KIM

Journal of Korean Society for Clinical Pharmacology and Therapeutics.2011;19(1):40-51.

BACKGROUND: This study was aimed to investigate the current two years' clinical research coordinators (CRCs) employment and estimate total number of CRCs in Korea. METHODS: The participants were administrative officers or head CRCs in institutions designated by Korea Food & Drug Administration (KFDA). Data on the current status of CRCs' employment was collected with self-administered questionnaires or telephone interview. And total number of CRCs in Korea was estimated based on ratio between the number of the KFDA approved clinical trials and current number of CRCs. RESULTS: The number of CRCs was 1381 at 36 centers in 2009 and 1444 at 37 centers in 2010. About 79 percent of CRCs were employed by investigators. The estimated number of CRCs was from 1677 to 1763 at 135 centers in 2009 and from 1802 to 1890 at 142 centers in 2010 based on number of clinical trials approved by KFDA. Two third of regional clinical trial centers (RCTCs) had written employment policy, and 25 percent of RCTCs employed CRCs in a regular position. All RCTCs had educational programs for CRCs and supported CRCs for training outside. 75 percent of RCTCs provided ID card for CRCs belonging to investigators to access to hospital document. Half of RCTCs had CRC registration system in hospital-wide. CONCLUSION: The number of CRCs in Korea can be easily estimated with the number of KFDA approved clinical trials. Majority of RCTCs still employed CRCs in an irregular position, which should be switched to regular position to reduce the CRCs' unsatisfaction. It is also needed to develop centralized CRC management system for CRCs belonging to investigators.
Calcium Hydroxide ; Employment ; Head ; Humans ; Interviews as Topic ; Korea ; Surveys and Questionnaires ; Research Personnel ; Zinc Oxide

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Bioequivalence Study of Two Orally Disintegrating Risperidone Formulations, Risperdal OD(R) Tablet 1mg and Risperdal Quicklet(R) Tablet 1mg in Healthy Korean Volunteers.

Gaeun KANG ; Jin KIM ; Kyung Yeol BAE ; Hee Young SHIN ; Seong Wook JEONG ; Jin Sang YOON ; Jong Keun KIM

Journal of Korean Society for Clinical Pharmacology and Therapeutics.2011;19(1):31-39.

BACKGROUND: Risperidone is one of the atypical antipsychotic drugs that have effectiveness in the management of a range of psychiatric illnesses. Orally disintegrating (OD) formulations of risperidone that rapidly dissolve in the mouth, prior to swallowing without water have been developed to overcome any problems related to swallowing and improve acceptability. The goal of this study was to evaluate the bioequivalence of Risperdal OD(R) tablet 1mg and Quicklet(R) tablet 1mg. METHODS: This randomized, open-label, 2-way crossover trial was conducted in 36 healthy male volunteers that received OD risperidone tablet, either the reference formulation (Risperdal Quicklet(R) tablet 1mg), or the test formulation (Risperdal OD(R) tablet 1mg), each in a single administration. Blood samples were obtained during a 24-hour period after dosing. Plasma was analyzed for risperidone by a validated LC-MS/MS. Adverse events were monitored by safety assessments including clinical interview by clinician. Pharmacokinetics were calculated by noncompartmental analysis and compared between two formulations. RESULTS: A total of 36 male volunteers (mean age, 24.2 years; height 174.5 cm; weight 67.6 kg) completed the study. The ANOVA showed no significant effect of sequence, formulation and period of Ln (AUClast) and Ln (Cmax). The 90% confidence intervals for the mean treatment ratios of the Ln (AUClast) and Ln (Cmax) were Ln 0.96 ~ Ln 1.12, Ln 0.97 ~ Ln 1.16, respectively. No serious adverse events were caused by both formulations. CONCLUSION: In this study, a single administration of Risperdal OD(R) tablet 1mg was bioequivalent to a single administration of Risperdal Quicklet(R) tablet 1mg.
Antipsychotic Agents ; Deglutition ; Humans ; Male ; Mouth ; Plasma ; Risperidone ; Therapeutic Equivalency

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Recognition of Clinical Research Coordinators among Non-Nursing Major Students.

Ihn sook JEONG

Journal of Korean Society for Clinical Pharmacology and Therapeutics.2011;19(1):23-30.

BACKGROUND: This study was aimed to investigate recognition of clinical research coordinators (CRCs) among non-nursing major students. METHODS: The participants were 424 undergraduate or graduate students whose majors were related to life science, physical therapy or pharmaceutical engineering in three universities located in Busan. Data were collected with self administrated questionnaire including general characteristics (5 items), and recognition of CRCs (4 items). The collected data were coded and was analyzed using SPSS Version 18.0 for Windows for frequency and percentage, or mean and standard deviation. The Chi-squared test was used to assess the relationship between general characteristics and recognition of CRCs. All statistical tests were performed at the 0.05 level of significance for two-tailed tests. RESULTS: The percent of 'ever having heard of CRCs' was 28.3 % and 35.0 % of them showed the intention to work as CRCs. The 'ever having heard of CRCs' was related to major (p<0.001) and 'ever having heard of clinical trials' (p<0.001). The intention to work as CRCs was not related to gender, education, major, and 'ever having heard of clinical trials'. CONCLUSION: The level of 'ever having heard of CRCs' among non-nursing major students was lower than that of nurses. It is needed that more active introduction or promotion of CRCs to non-nursing major students through both regular curriculum or training programs. And it is also recommended to develop the job description for CRCs with nurse license or CRCs without nurse license.
Biological Science Disciplines ; Calcium Hydroxide ; Curriculum ; Humans ; Intention ; Job Description ; Licensure ; Surveys and Questionnaires ; Zinc Oxide

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Reasons for Investigators to Participate Industry Sponsored Clinical Trials.

Joon Hyung KIM ; Won CHOI ; Sung Ho BECK ; Soo Jeong PARK ; Soo Yeon PARK ; Woo Yun SOHN ; Hyun Ho KIM ; Seung Soo KIM ; Hankyu LEE ; Jung Ryun AHN ; Yoon Jung KIM ; Jung Min SEO ; Chung Mo NAM ; Yil Seob LEE

Journal of Korean Society for Clinical Pharmacology and Therapeutics.2011;19(1):14-22.

BACKGROUND: It is getting more difficult to involve appropriate investigators in clinical trials. Knowing what investigators want from sponsor initiated clinical trials would help industry cooperate with investigators more efficiently. This study aims to describe the incentives for investigators choosing to participate or not and perform well in sponsored clinical trials. METHODS: Investigators who have participated in GSK sponsored clinical trials were interviewed face-to-face or through e-mail using the standardized questionnaire. Investigators were asked to choose five items and determine the ranking or those five items. RESULTS: Questionnaires answered by 122 investigators were collected. The top three incentives were "Academic merit" (108, 88.5 %), "Expectation of treatment potentially helpful to patient" (101, 82.8 %), and "Access to new treatments" (92, 75.4 %). The disincentives and the factors affecting an investigator's performance were analyzed separately because of the different questionnaire between investigators for medicine and vaccine. Investigators for medicine choose as disincentives "Insufficient time" (43, 61.4 %), "Difficult protocol" (41, 58.6 %), and "Adverse event concerns" (41, 58.6 %). Vaccine investigators pointed out "Limited support staff" (41, 78.8 %), "Insufficient time" (40, 76.9 %), and "Difficult blood sampling" (333, 63.5 %) as disincentives. Factors adversely affecting an investigator's performance showed similar results to those of disincentives. CONCLUSION: Investigators focused on academic curiosity and patients and insufficient time mostly inhibits them from participating and performing clinical trials. Our results would help industry cooperate with investigators more efficiently, finally making companies perform clinical trials more effectively.
Electronic Mail ; Exploratory Behavior ; Humans ; Motivation ; Surveys and Questionnaires ; Research Personnel

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The Suggestions for Improving the Institutional Review Board (IRB) in Clinical Trials: Focusing on Continuing Management.

Hee Young SHIN

Journal of Korean Society for Clinical Pharmacology and Therapeutics.2011;19(1):5-13.

As Korea has increasing number of clinical trials in recent years, institutional review boards (IRBs) are facing new challenges. The IRB should review submitted documents and supervise clinical trials from the beginning to the end to protect human subjects. Although most IRBs invest much time and efforts to initial review, they rarely conduct proper continuing management at the moment. The purpose of this article is to describe challenges involving continuing management, which includes unanticipated problems, subject's complaints, site visit, and continuing review, and to provide suggestions for improving it. Above all, institutions should perceive the importance of continuing management and they should provide sufficient manpower and resources for the management.
Ethics Committees, Research ; Ethics, Research ; Humans ; Korea

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Statistical Analysis System of Spontaneous Adverse Drug Reaction Reports.

Sira KIM ; Boram WANG ; Jungsun LEE ; Bori KIM ; Hyeno LA ; Young Min PARK ; Inyoung CHOI

Journal of Korean Society for Clinical Pharmacology and Therapeutics.2012;20(2):155-164. doi:10.12793/jkscpt.2012.20.2.155

BACKGROUND: Spontaneous adverse drug reaction (ADR) reporting data has been used for safety of post-market drug surveillance. A system has been required that is able to detect signals associated with drugs by analyzing the collected ADR data. METHODS: We developed the web-based automated analysis system (ADR-detector). We used the data which reported ADR spontaneously between March 2009 and December 2010 to Korean Food and Drug Administration. We used 3 statistical indicators for evaluating ADR signals: proportional reporting ratio (PRR), reporting odds ratio (ROR), and information component (IC). The ADR reports which were detected as significant signals based on the indicators have been reviewed. RESULTS: Among 153,774 reports, 9,955 cases were related to 4 analgesics which were most frequently reported analgesic drugs during the study period. The numbers of ADR reports associated with each drug are as follow: 5,623 reports in tramadol (56.5 %), 1,720 reports in fentanyl (17.3 %), 1,463 reports in tramadol-combination (14.7 %), and 1,149 reports in ketorolac (11.5 %). Top 5 ADR were nausea (3,351 reports - 33.7 %), vomiting (1,755 reports - 17.6 %), dizziness (1,130 - 11.4 %), rash (412 reports - 4.1 %), and pruritus (354 reports - 3.6 %). 6,674 ADR reports were significant based on PRR and ROR, and 336 reports were significant based on IC. CONCLUSION: By using the automated analysis system, not only statisticians but also general researchers are able to analyze ADR signals in real-time. Also ADR-detector would provide rapid review and cross-check of ADR.
Analgesics ; Data Mining ; Dizziness ; Drug Toxicity ; Exanthema ; Fentanyl ; Ketorolac ; Nausea ; Odds Ratio ; Pruritus ; Tramadol ; United States Food and Drug Administration ; Vomiting

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Bioequivalence and Dose Proportionality of Olmesartan Medoxomil Formulations.

Sung Kweon CHO ; Choon Ok KIM ; Su Hyun YU ; Eun Sil OH ; Seong Bok JANG ; Yoong Sik PARK ; Kyunghee CHO ; Jae Yong CHUNG

Journal of Korean Society for Clinical Pharmacology and Therapeutics.2012;20(2):145-154. doi:10.12793/jkscpt.2012.20.2.145

BACKGROUND: Olmesartan medoxomil is an angiotensin II receptor blocker commonly used in hypertension. First objective of this study was to evaluate the bioequivalence of two olmesartan formulations, Olmesartan 20 mg and 40 mg tablet (Yuhan, Pharmaceutical Corp. Seoul, Korea) as test drugs and Olmetec(R) 20 mg and 40 mg tablet (Daewoong, Pharmaceutical Corp. Seoul, Korea) as reference drugs. Second objective of this study was to evaluate the dose-proportionality of two formulations. METHODS: Two studies (20 mg, 40 mg) were conducted as a randomized, open-label, 2-period, crossover design. Each subject received one 20 mg or 40 mg tablet of the reference or test formulation of olmesartan medoxomil in each study. Blood samples were obtained during the 48-hour period after the dose in each treatment period. Wash-out period was 1 week in each study. Concentrations of olmesartan medoxomil in plasma were analyzed using a liquid chromatography system with tandem mass-spectrometric detection (LC/MS/MS). The primary pharmacokinetic parameters were Cmax (maximum concentration) and AUCt (area under the concentration-time curve from time 0 to the last sampling time). RESULTS: A total number of 40 healthy male volunteers participated in the study and 37 volunteers completed both treatment periods in 20 mg trial. All 40 participants completed both treatment periods in 40 mg trial. The 90 % CIs for the geometric mean ratios of the pharmacokinetic parameters (test:reference drug) were 0.93 ~ 1.04 for AUCt and 0.97 ~ 1.08 for Cmax in 20 mg trial. The 90 CIs were 0.94 ~ 1.02 for AUCt and 1.00 ~ 1.11 for Cmax in 40 mg trial. All parameters of two studies satisfy the range of bioequivalence criterion. CONCLUSION: The obtained results indicated that pharmacokinetic exposure to Olmesartan 20 mg and 40 mg tablet was bioequivalent to that of Olmetec(R) 20 mg and 40 mg tablet, respectively.
Chromatography, Liquid ; Cross-Over Studies ; Humans ; Hypertension ; Imidazoles ; Male ; Plasma ; Receptors, Angiotensin ; Tetrazoles ; Therapeutic Equivalency

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Comparison of Pharmacokinetics and Safety of Two Formulations of Letrozole (2.5 mg) in Healthy Male Volunteers.

Yook Hwan NOH ; Kyun Seop BAE ; Sang Heon CHO ; Sangmin CHOE ; Jong Lyul GHIM ; Jin Ah JUNG ; Un Jib KIM ; Seok Joon JIN ; Hyun Jung PARK ; Jung Chul KIM ; Hyeong Seok LIM

Journal of Korean Society for Clinical Pharmacology and Therapeutics.2012;20(2):135-144. doi:10.12793/jkscpt.2012.20.2.135

BACKGROUND: Letrozole is an oral non-steroidal inhibitor of the aromatase enzyme, which has proven to be a useful drug against breast cancer. METHODS: This single-dose, randomized 2 x 2 crossover study was conducted in healthy male volunteers. Participants of each sequence group (each 13 volunteers for sequence group) received, in randomized sequence, a single oral 2.5-mg dose of generic letrozole (test) or branded letrozole (reference). Each treatment period was separated by a 5-week washout period. Blood samples were collected for up to 312 hours after drug administration, and drug concentrations were determined using validated LC/MS-MS. Pharmacokinetic properties were obtained using noncompartmental analysis. Drug tolerability was assessed throughout the study, using measurements of vital signs, physical examination, clinical chemistry testing, EKG, and interviews. RESULTS: A total of 26 subjects completed the study. The geometric mean ratios (90% CI) of Cmax and AUClast were 0.92 (0.85 - 0.99) and 1.01 (0.97 - 1.04), respectively. No serious AEs were reported, and there were no clinically significant differences between test and reference groups. CONCLUSION: The findings from this study suggest bioequivalence between two formulations of letrozole in healthy male volunteers. The safety profile of two formulations had similar characteristics.
Aromatase ; Breast ; Clinical Chemistry Tests ; Cross-Over Studies ; Electrocardiography ; Humans ; Male ; Nitriles ; Physical Examination ; Therapeutic Equivalency ; Triazoles ; Vital Signs

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Tolerability and Pharmacokinetics Following a Single Dose of Vardenafil in Healthy Korean Volunteers.

Seokuee KIM ; Seunghwan LEE ; Kyoung Soo LIM ; Hyeong Seok LIM ; Sang Goo SHIN ; In Jin JANG ; Kyung Sang YU

Journal of Korean Society for Clinical Pharmacology and Therapeutics.2012;20(2):125-134. doi:10.12793/jkscpt.2012.20.2.125

BACKGROUND: Vardenafil is a phosphodiesterase type 5 inhibitor, used in erectile dysfunction. This study aimed to evaluate the pharmacokinetics and tolerability of vardenafil following a single oral administration in healthy male subjects. METHODS: A randomized, double-blind, placebo-controlled, single dosing, dose-escalation study was conducted in 30 healthy subjects. A single oral dose of vardenafil or placebo was given to 10 subjects (8 active + 2 placebo) in each dose group of 5, 10 and 20 mg. Serial blood and urine samples were obtained up to 48 hours for pharmacokinetic analysis. Vardenafil and its metabolite were detected by high performance liquid chromatography tandem mass spectrometry assay. RESULTS: A total of 45 adverse events (AE) were reported in 22 subjects, including 5 AEs from placebo treatment, and all the AEs were mild, except one case of moderate nasal stuffiness. Vardenafil was absorbed after a single oral dose, with the tmax of 0.5-1.0 hours. The Cmax and AUClast were 10.21 +/- 3.68 ug/L(mean +/- SD) and 18.08 +/- 7.44 ugxh/L in 5 mg dose group, 19.79 +/- 12.13 ug/L and 38.61 +/- 21.04 ugxh/L in 10 mg dose group and 53.16 +/- 37.01 ug/L and 110.05 +/- 69.65 ugxh/L in 20 mg dose group. Dose-linearity on AUClast and Cmax of vardenafil were observed in three dose groups. In all dose groups, the fraction excreted in urine was less than 1%. CONCLUSION: The vardenafil was tolerable over a single dose range of 5 - 20 mg. The pharmacokinetics of vardenfil after a single oral dose was explored and linear pharmacokinetic characteristics were observed over the dose range of 5 - 20 mg in healthy subjects.
Administration, Oral ; Chromatography, Liquid ; Erectile Dysfunction ; Humans ; Imidazoles ; Male ; Piperazines ; Sulfones ; Tandem Mass Spectrometry ; Triazines

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