• Parasites, Hosts and Diseases
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• v.44 no.4 s.140
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• pp.361-366
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• 2006

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 $AUC_{last}$ of SRP was $497.9{\pm}519.0ng{\cdot}hr/ml\;(mean{\pm}SD)$ and PZQ of $628.6{\pm}695.5\;ng{\cdot}hr/ml$, and the $AUC_{inf}$ of SRP was $776.0{\pm}538.5\;ng{\cdot}hr/ml$ and of PZQ $658.6{\pm}709.9\;ng{\cdot}hr/ml$. $C_{max}$ values of SRP and PZQ were $90.7{\pm}82.2ng/ml\;and\;214.9{\pm}251.9\;ng/ml$, and $T_{max}$ values were $3.42{\pm}1.43\;hr\;and\;1.96{\pm}1.23\;hr$, respectively. SRP tablets showed similar AUC values, but lower $C_{max}$ and longer $T_{max}$ 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.

• Journal of Gastric Cancer
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• v.19 no.2
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• pp.157-164
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• 2019

Purpose: Although standard radical gastrectomy is recommended after noncurative resection of endoscopic submucosal dissection (ESD) for early gastric cancer in most cases, residual tumor and lymph node metastasis have not been identified after surgery. The aim of this study is to evaluate the feasibility of sentinel node navigation surgery after noncurative ESD. Materials and Methods: This trial is an investigator-initiated, multicenter prospective phase II trial. Patients who underwent ESD for clinical stage T1N0M0 gastric cancer with noncurative resections were eligible. Qualified investigators who completed the prior phase III trial (SENORITA 1) are exclusively allowed to participate. In this study, 2 detection methods will be used: 1) intraoperative endoscopic submucosal injection of dual tracer, including radioisotope and indocyanine green (ICG) with sentinel basins detected using gamma-probe; 2) endoscopic injection of ICG, with sentinel basins detected using a fluorescence imaging system. Standard laparoscopic gastrectomy with lymphadenectomy will be performed. Sample size is calculated based on the inferior confidence interval of the detection rate of 95%, and the calculated accrual is 237 patients. The primary endpoint is detection rate, and the secondary endpoints are sensitivity and postoperative complications. Conclusions: This study is expected to clarify the feasibility of laparoscopic sentinel basin dissection after noncurative ESD. If the feasibility is demonstrated, a multicenter phase III trial will be initiated to compare laparoscopic sentinel node navigation surgery versus laparoscopic standard gastrectomy in early gastric cancer after endoscopic resection.

• The Journal of Pediatrics of Korean Medicine
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• v.37 no.3
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• pp.75-93
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• 2023

Objectives We aimed to analyze the registration status of interventional clinical trials in children and adolescents with chronic cough. Methods All interventional clinical trials registered up to 3 July, 2023 on the international clinical trial registry platform (ICTRP) of the World Health Organization (WHO) were analyzed. Information was extracted including study design, interventions, inclusion and exclusion criteria, and outcome indicators. Results A total of 18 interventional clinical trials were analyzed. For study design, multicentre trials, randomized allocation, parallel group design and phase 4 trials were the most frequently reported. Blinding was used in 44.4% and informed consents were obtained from 61.1%. For intervention, drugs were used in 61.1%, using placebo control group in 27.8%. Quality of life questionnaires were most frequently reported in 50% as the primary outcome, and adverse events were the most as the secondary outcome. In most cases, the assessment timepoints were after two weeks. Conclusions Based on the characteristics of clinical trial design analyzed in this study, it is necessary to design traditional Korean medicine clinical trials with improved quality and accuracy of information.

• The Journal of Korean Obstetrics and Gynecology
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• v.20 no.3
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• pp.213-228
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• 2007

Purpose: This master‘s thesis to evaluate the grade of life after medication a Dangguijakyak-san(pasabu) and Gyejibongnyeong-hwan(cheongwal) with in postmenopausal women get lowering quality of life caused by vasomotor symptoms with hot flush. Methods: A subject who signing on the clinical trial written consent by self-will is registered this clinical trial after decided suitable by selection and exception standard, after take a medical experiment and checkup according to clinical trial plan. Registered subject should valuated by settled schedule after take the testing medicine 1,2 during thirty-day. In this period, a subject allocated at relatively better suited experimental group by oriental doctor after consideration of general efficacy and nature of a medicine at second visiting. Results: The result of comparison in the remedial value with sixteen patients who ended the experiment is like next list. 1. There's no regarded difference of comparison in general conditions between two patient groups. 2. There's no regarded difference during observation period before take medicine. 3. By period of measurement, there's something regarded differences most of patients of two parts after taking medicine. 4. There's no regarded difference at alteration phase of each standard according to kind of medicine. 5. There's no abnormal views reflected at allergy, Laboratory and Physical Examination during experiment. Conclusion: This experiment evidence a Dangguijakyak-san and Gyejibongnyeong-hwan can help for improvement generally life quality of postmenopausal women and certify safety of herbs.

• Korean Journal of Clinical Pharmacy
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• v.16 no.1
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• pp.23-27
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• 2006

Doxorubicin (DXR) is a type of anti-cancer drug called an 'anthracycline glycoside', It works by impairing DNA synthesis, a crucial feature of cell division, and thus is able to target rapidly dividing cells. Doxorubicin is a very serious anti-cancer medication with definite potential to do great harm as well as great good. A liquid chromatography-tandem mass spectroscopy (LC-MS/MS) method was developed to identify and quantify DXR in small-volume biological samples. After the addition of internal standard (IS, $5{\mu}L\;of\;1{\mu}M/ml$ daunorubicin methanol solution) into the serum sample, the drug and IS were extracted by methanol. Following vortex for a 1min and centrifugation at 15,000g for 10 min the organic phase was transferred and evaporated under a vacuum. The residue was reconstituted with $350{\mu}L$ of mobile phase and $10{\mu}L$ was injected into C18 column with mobile phase composed of 0.05M ammonium acetate (0.1 M acetic acid adjusted to pH 3.5) and acetonitrile (40:60, v/v). The flow rate was kept constant at $350{\mu}L/min$. The ions were quantified in the multiple reaction mode (MRM), using positive ions, on a triple quadrupole mass spectrometer. The lower limits of quantification for Doxorubicin in plasma and small tissues were approximately 0.5 ng/mL and 0.5 ng/mL respectively. Intra- and inter-assay accuracy (% of nominal concentration) and precision (% CV) for all analytes were within 15%, respectively.

• Journal of Acupuncture Research
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• v.25 no.2
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• pp.227-242
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• 2008

Objectives : To compare the efficacy of local acupoint with distal acupuncture at relieving pain and improving function in knee osteoarthritis. Designs : A randomized, single-blinded, crossover clinical trial. Settings : One outpatient clinic(department of acupuncture & moxibustion) located in academic teaching hospital, South Korea. Patients : 17 patients with osteoarthritis of the knee(mean age 62.76[$SD{\pm}4.37$] years). Interventions : The trial had 4 stages : baseline(2weeks), phase I and II(each 2weeks), washout period(2weeks). Patients were randomly assigned to either group A or group B. Group A received acupuncture at local acupoints during phase I, then acupuncture at distal acupoints in phase II. Group B received the treatments in reverse order. In each phase, the patients were treated with acupuncture for 6 times. Measurements : The primary outcome was subjective pain as measured by a 100mm visual analogue scale(VAS) ranging from 0(no pain) to 10(worst pain ever). Secondary outcomes were changes in the Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC) total and pain scores. Measurements were obtained at baseline, 1st day of phase I and II, and 2 days after last treatment of phase I and II. Results : The 17 participants in 2 groups were well matched for age, sex, target knees, baseline VAS score, WOMAC pain score and WOMAC score. Participants in local acupoint group experienced greater improvement than distal acupoint group at 2 days after last treatment in WOMAC total score(mean difference, -10.65[95% CI, -20.56 to -0.74] ; P=0.036) but not in VAS(mean difference, -12.41[95% CI, -29.56 to 4.73] P=0.15) and WOMAC pain score(mean difference, -1.82[95% CI, -3.98 to 0.33] ; P=0.094). Conclusions : Local acupoints are more effective than distal acupoints at relieving pain and improving function in knee osteoarthritis.

• The Korean Journal of Applied Statistics
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• v.32 no.1
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• pp.1-13
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• 2019

An adaptive seamless Phase II/III clinical trial design enables a reduction in the sample size (in comparison to a conventional design) that also shortens the clinical development time. It is also very effective in clinical trials since it can have higher statistical power than Phase III alone. In this study, we use extensive simulation studies to compare several multiple hypothesis testing methods that can help select the best doses in a Phase II study along with several methods to combine p-values of the Phase II and Phase III study.

• Proceedings of the PSK Conference
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• 2002.10a
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• pp.223-224
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• 2002

Pharmacokinetic (PK) and pharmacodynamic (PD) study of a new reversible proton pump inhibitor (YH1885, Yuhan Pharmaceutical Co.) was done as a phase 1 clinical trial in Seoul national University Hospital Clinical trialcenter. Single dose of 60, 100, 150, 200, and 300mg were administered to total 20 healthy subjects under fasting state. Six subjects were given 100 mg after food and 12 subjects were given multiple doses of 150 and 300 mg every day for 7 days under fasting state. (omitted)

• Journal of Pharmaceutical Investigation
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• v.36 no.1
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• pp.23-29
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• 2006

A rapid, selective and sensitive reversed-phase HPLC method for the determination of promethazine in human serum was developed, validated, and applied to the pharmacokinetic study of promethazine. Promethazine and internal standard, chlorpromazine, were extracted from human serum by liquid-liquid extraction with n-hexane containing 0.8% isopropanol and analyzed on a Capcell Pak CN column with the mobile phase of acetonitrile-0.2 M potassium dihydrogen phosphate (42:58, v/v, adjusted to pH 6.0 with 1 M NaOH). Detection wavelength of 251 nm and flow rate of 0.9 mL/min were fixed for the study. The assay robustness for the changes of mobile phase pH, organic solvent content, and flow rate was confirmed by $3^{3}$ factorial design using a fixed promethazine concentration (10 ng/mL) with respect to its peak area and retention time. In addition, the ruggedness of this method was investigated at three different laboratories using same quality control (QC) samples. This method showed linear response over the concentration range of 1-40 ng/mL with correlation coefficients greater than 0.999. The lower limit of quantification using 1 mL of serum was 1 ng/mL, which was sensitive enough for pharmacokinetic studies. The overall accuracy of the quality control samples ranged from 96.15 to 105.40% for promethazine with overall precision (% C.V.) being 6.70-11.22%. The relative mean recovery of promethazine for human serum was 63.54%. Stability (freeze-thaw and short-term) studies showed that promethazine was stable during storage, or during the assay procedure in human serum. However, the storage at $-80^{\circ}C$ for 4 weeks showed that promethazine was not stable. Extracted serum sample and stock solution were not allowed to stand at ambient temperature for 12 hr prior to injection. The peak area and retention time of promethazine were not significantly affected by the changes of mobile phase pH, organic solvent content, and flow rate under the conditions studied. This method showed good ruggedness (within 15% C.V.) and was successfully used for the analysis of promethazine in human serum samples for the pharmacokinetic studies of orally administered Himazin tablet (25 mg as promethazine hydrochloride) at three different laboratories, demonstrating the suitability of the method.

• IMMUNE NETWORK
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• v.21 no.1
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• pp.5.1-5.22
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• 2021

Coronavirus disease 2019 (COVID-19) has developed as a pandemic, and it created an outrageous effect on the current healthcare and economic system throughout the globe. To date, there is no appropriate therapeutics or vaccines against the disease. The entire human race is eagerly waiting for the development of new therapeutics or vaccines against severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2). Efforts are being taken to develop vaccines at a rapid rate for fighting against the ongoing pandemic situation. Amongst the various vaccines under consideration, some are either in the preclinical stage or in the clinical stages of development (phase-I, -II, and -III). Even, phase-III trials are being conducted for some repurposed vaccines like Bacillus Calmette-Guérin, polio vaccine, and measles-mumps-rubella. We have highlighted the ongoing clinical trial landscape of the COVID-19 as well as repurposed vaccines. An insight into the current status of the available antigenic epitopes for SARS-CoV-2 and different types of vaccine platforms of COVID-19 vaccines has been discussed. These vaccines are highlighted throughout the world by different news agencies. Moreover, ongoing clinical trials for repurposed vaccines for COVID-19 and critical factors associated with the development of COVID-19 vaccines have also been described.