A bioequivalence study of RoxithrinTM tablet (Kukje Pharma. Ind. Co., Ltd.) to RulidTM tablet (Han Dok Pharma. Ind. Co., Ltd.) was conducted according to the guidelines of Korea Food and Drug Administration (KFDA). Twenty four healthy male Korean volunteers received each medicine at the roxithromycin dose of 300 mg in a 2×2 crossover study. There was a one-week wash-out period between the doses. Plasma concentrations of roxithromycin were monitored by a high-performance liquid chromatography for over a period of 36 hours after drug administration. AUCt (the area under the plasma concentration-time curve from time zero to 36 hr) was calculated by the linear trapezoidal rule method. Cmax (maximum plasma drug concentration) and Tmax (time to reach Cmax) were compiled from the plasma concentration-time data. Analysis of variance was carried out using logarithmically transformed AUCt and Cmax. No significant sequence effect was found for all of the bioavailability parameters indicating that the cross-over design was properly performed. The 90% confidence intervals of the AUCt ratio and the Cmax ratio for RoxithrinTM/RulidTM were 1.00 - 1.13 and 0.98 - 1.10, respectively. These values were within the acceptable bioequivalence intervals of 0.80 - 1.25. Thus, our study demonstrated the bioequivalence of RoxithrinTM and RulidTM with respect to the rate and extent of absorption.
Jung, Eun Jung;Gwak, Hye Sun;Choi, Jun Shik;Lee, Jin Hwan;Li, Xiuguo
Korean Journal of Clinical Pharmacy
/
v.12
no.2
/
pp.91-95
/
2002
The pharmacokinetics of intravenous paclitaxel (1 mg/kg) were investigated in rabbits with renal failure induced by folic acid. The area under the plasma concentration-time curve from time zero to time infinity (AUC) of paclitaxel was significantly (p<0.05) greater in rabbits with severe renal failure induced by folic acid (1030±382) compared to that in rabbits with in moderate renal failure induced by folic acid (780±209ng/ml⋅hr). The apparent volume of distribution (Vd) (0.008±0.002L/kg) and the elimination rate constant (β)(0.09±0.025hr−1) of paclitaxel in rabbits with severe renal failure were significantly (p<0.05) smaller and slower respectively than those of control rabbits (0.016±0.004L/kg,0.12±0.03hr−1), but not significantly different compared with that in rabbits with moderate renal failure (0.010±0.003L/kg,0.10±0.026hr−1). total body clearance (CL) of paclitaxel in rabbits with severe renal failure (0.97±0.183L/hr/kg) was significantly (p<0.05) slower than that in control rabbits (1.68±0.440L/hr/kg), but not significantly different compared with that in rabbits with in moderate renal failure (1.28±0.311L/hr/kg). The terminal half-life (t1/2) of paclitaxel in rabbits with severe renal failure (7.46±2.16hr) was significantly (p<0.05) longer than that in control rabbits (5.75±1.44hr), but not significantly different compared to that in rabbits with moderate renal failure rabbits (6.67±1.76hr). The above data could be at least partly decrease in due to paclitaxel excretion in rabbits with renal failure, since 7−15% of interavenous paclitaxel was excreted via kidney as unchanged forms plus its metablites.
Titanium and its alloys are finding increasing use in medical devices and dental implants. The strong selling point of titanium is its resistance to the highly corrosive body fluids in which an implant must survive. This corrosion resistance is due to a tenacious passive oxide or film which exists on the metal's surface and renders it passive. Potentiodynamic polarization measurement is one of the most commonly used electro-chemical methods that have been applied to measure corrosion rates. And the potentiodynamic polarization test supplies detailed information such as open circuit, rupture, and passivation potential. Furthermore, it indicates the passive range and sensitivity to pitting corrosion. This study was designed to compare the corrosion resistance of the commonly used dental implant materials such as CP Ti, Ti-6A1-4V, Co-Cr-Mo alloy, and 316L stainless steel. And the effects of galvanic couples between titanium and the dental alloys were assessed for their useful-ness-as. materials for superstructure. The working electrode is the specimen , the reference electrode is a saturated calomel electrode (SCE), and the counter electrode is made of carbon. In N2−saturated 0.9% NaCl solutions, the potential scanning was performed starting from -800mV (SCE) and the scan rate was 1 mV/sec. At least three different polarization measurements were carried out for each material on separate specimen. The galvanic corrosion measurements were conducted in the zero-shunt ammeter with an implant supraconstruction surface ratio of 1:1. The contact current density was recorded over a 24-hour period. The results were as follows : 1. In potential-time curve, all specimens became increasingly more noble after immersion in the test solution and reached between -70mV and 50mV (SCE) respectively after 12 hours. 2. The Ti and Ti alloy in the saline solution were most resistant to corrosion. They showed the typical passive behavior which was exhibited over the entire experimental range. Therefore no breakdown potentials were observed. 3. Comparing the rupture potentials, Ti and Ti alloy had the high(:st value (because their break-down potentials were not observed in this study potential range ) followed by Co-Cr-Mo alloy and stainless steel (316L). So , the corrosion resistance of titanium was cecellent, Co-Cr-Mo alloy slightly inferior and stainless steel (316L) much less. 4. The contact current density sinks faster than any other galvanic couple in the case of Ti/gold alloy. 5. Ag-Pd alloy coupled with Ti yielded high current density in the early stage. Furthermore, Ti became anodic. 6. Ti/Ni-Cr alloy showed a relatively high galvanic current and a tendency to increase.
Kim, Chong-Kook;Jeong, Eun-Ju;Lee, Eun-Jin;Shin, Hee-Jong;Lee, Won-Keun
Journal of Pharmaceutical Investigation
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v.23
no.1
/
pp.41-49
/
1993
The bioequivalence of two omeprazole enteric-coated products was evaluated in 16 normal male volunteers (age 26-32 yr, body weight 57-75 kg) following single oral administration. Test product was enteric-coated KD-182 tablet (Chong Kun Dang Corp., Korea) and reference product was Rosec® capsule containing enteric-coated pellets of omeprazole (Yuhan Corp., Korea). Both products contain 20 mg of omeprazole. One tablet or capsule of the test or the reference product was administered to the volunteers, respectively, by randomized two period cross-over study (2×2 Latin square method). Average drug concetrations at each sampling time and pharmacokinetic parameters calculated were not significantly different between two products(p>0.05); the area under the concentrationtime curve to last sampling time (8 hr) (AUC0−8hr)(1946.5±675.3vs2018.3±761.6ng⋅hr/ml), AUC from time zero to infinite (AUCo−∞)(2288.6±1212.8vs2264.9±1001.3ng⋅hr/ml), maximum plasma concentration (Cmax)(772.5±283.3vs925.8±187.7ng/ml), time to maximum plasma concentration (Tmax)(2.38±1.06vs2.34±1.09hr), apparent elimination rate constant (kℓ)(0.5339±0.2687vs0.5769±0.2184hr−I), apparent absorption rate constant (ka)(1.1536±0.5278vs0.9739±0.9507hr−1) and mean residence time (MRT) (3.13±0.73vs3.41±1.04hr). The differences of mean (AUC0−8hr), Cmax, Tmax and MRT between the two products (3.69, 19.83, 1.32 and 8.99%, respectively) were less than 20%. The power (1−β) and treatment difference (△) for AUCo−8hrCmax and MRT were more than 0.8 and less than 0.2, respectively. Although the power for Tmax was under 0.8, Tmax of the two products was not significantly different each other(p>0.05). These results suggest that the bioavailability of KD-182 tablet is not significantly different from that of Rosec® capsule. Therefore, two products are bioequivalent based on the current results.
A bioequivalence of EtodolTM tablets (Yuhan corporation) and KuhnillodineTM tablets (Kuhnil Pharm. Co., Ltd.) was evaluated according to the guideline of Korea Food and Drug Administration (KFDA). Single 200 mg dose of etodolac of each medicine was administered orally to 24 healthy male volunteers. This study was performed in a 2×2 crossover design. Concentrations of etodolac in human plasma were monitored by a high-performance liquid chromatography. AUCt (the area under the plasma concentration-time curve from time zero to 24 hr) was calculated by the linear trapezoidal rule method. Cmax (maximum plasma drug concentration) and Tmax (time to reach Cmax) were compiled from the plasma concentration-time data. Analysis of variance was performed using logarithmically transformed AUCt and Cmax. No significant sequence effect was found for all of the bioavailability parameters. The 90% confidence intervals of the AUCt ratio and the Cmax ratio for EtodolTM/KuhnillodineTM were 1.01-1.10 and 0.87-1.06, respectively. This study demonstrated a bioequivalence of EtodolTM and KuhnillodineTM with respect to the rate and extent of absorption.
Park, Chang-Hun;Joung, Sun-Koung;Choi, Mee-Hee;Kim, Ho-Hyun;Lee, Ye-Rie;Lee, Hee-Joo;Lee, Kyung-Ryul
Journal of Pharmaceutical Investigation
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v.34
no.6
/
pp.505-511
/
2004
A bioequivalence study of BestidineTM tablets (Choong Wae Pharma. Corp., Korea) to Dong-A GasterTM (Dong-A Pharmaceutical Co., Ltd., Korea) tablets was conducted according to the guidelines of Korea Food and Drug Administration (KFDA). Twenty four healthy male Korean volunteers received each medicine at the famotidine dose of 40 mg in a 2×2 crossover study. There was a one-week wash out period between the doses. Plasma concentrations of famotidine were monitored by a high-performance liquid chromatography for over a period of 12 hours after the administration. AUCt (the area under the plasma concentration-time curve from time zero to 12 hr) was calculated by the linear trapezoidal rule method. Cmax (maximum plasma drug concentration) and Tmax (time to reach Cmax) were compiled from the plasma concentration-time data. Analysis of variance was carried out using logarithmically transformed AUCt and Cmax. No significant sequence effect was found for all of the bioavailability parameters indicating that the crossover design was properly performed. The 90% confidence intervals of the AUCt ratio and the Cmax ratio for BestidineTM/GasterTM were log 0.90-log 1.06 and log 0.98-log 1.20, respectively. These values were within the acceptable bioequivalence intervals of 0.80-1.25. Thus, our study demonstrated the bioequivalence of BestidineTM and GasterTM with respect to the rate and extent of absorption.
The present study describes the evaluation of the bioequivalence of two atorvastatin tablets, Lipitor Tablet(R) (Pfizer, reference drug) and Atorva Tablet(R) (Yuhan, test drug), according to the guidelines of Korea Food and Drug Administration (KFDA). Forty-nine healthy male Korean volunteers received each medicine at the atorvastatin dose of 40 mg in a 2×2 crossover study with a two weeks washout interval. After drug administration, serial blood samples were collected at a specific time interval from 0-48 hours. The plasma atorvastatin concentrations were monitored by an high performance liquid chromatography -tandem mass spectrometer (LC-MS/MS) employing electrospray ionization technique and operating in multiple reaction monitoring (MRM) and positive ion mode. The total chromatographic run time was 4.5 min and calibration curves were linear over the concentration range of 0.1-100 ng/mL for atorvastatin. The method was validated for selectivity, sensitivity, linearity, accuracy and precision. AUCt (the area under the plasma concentration-time curve from time zero to 48hr) was calculated by the linear log trapezoidal rule method. Cmax (maximum plasma drug concentration) and Tmax (time to reach Cmax) were complied trom the plasma concentration-time data. Analysis of variance was carried out using logarithmically transformed AUCt and Cmax. No significant sequence effect was found for all of the bioavailability parameters indicating that the crossover design was properly performed. The 90% confidence intervals of the AUCt ratio and the Cmax ratio for Atorva Tablet(R) / Lipitor Tablet(R) were log0.9413∼log1.0179 and log0.831∼log1.0569, respectively. These values were within the acceptable bioequivalence intervals of log0.8∼log1.25. Based on these statistical considerations, it was concluded that the test drug, Atorva Tablet(R) was bioequivalent to the reference drug, Lipitor Tablet(R).
The bioequivalence of two clarithromvcin products was evaluated with 16 normal male volunteers (age 23-28 yr, body weight 57.5-75.517g) following single oral dose. Test product was ReYon Clarithromycin tablets (ReYon Pharm. Corp., Korea) and reference product was Klarici dR tablets (Abbott Korea). Both products contain 250 mg of clarithromucin. One tablet of the test or the reference product was administered to the volunteers, respectively, by randomized two period cross-over study (2×2 Latin square method). The determination of clarithromycin was accomplished using a modified agar well diffusion bioassay. As a result of the assay validation, the quantification of clarithromycin in human serum by this technique was possible down to 0.03μg/ml using 100μl of serum. The coefficient of variation (C.V.) was less than 10%. Average drug concentrations at each sampling time and pharmacokinetic parameters calculated were not significantly different between two products P>0.05); the area under the curve to last sampling time (24 hr) (AU Co24hr (8.10± 1.26 vs 8.22± 1.627g . hr/ml), AUC from time zero to infinite (AU Co∞) (8.61 ± 1.28 vs 8.84± 1.71 μg . hr/ml), maximum plasma concentration ( Cmsx) (0.87±0.22 vs 0.88±0.19 μg/ml) and time to maximum plasma concentration ( Tmax) (2.69 ±0.48 vs 2.56± 0.51 hr). The differences of mean AU Co24h, Cmsx and Tmsx between the two products (1.44, 1.39, and 4.65%, respectively) were less than 20%. The power (1-β) and treatment difference (Δ) for AU Co24hr, and Cmax were more than 0.8 and less than 0.2, respectivly. Although the power for Tmax was under 0.8, Tmax. of the two products was not significantly different each other (p>0.05). These results suggest that the bioavailability of ReYon Clarithromycin tablets is not significantly different from that of Klarici dR tablets. Therefore, two products are bioequivalent based on the current results. results.sults.sults.s.s.s.s.s.s.s.
Background: Ginsenoside compound K (CK) is a promising drug candidate for rheumatoid arthritis. This study examined the impact of polymorphisms in NR1I2, adenosine triphosphate-binding cassette (ABC) transporter genes on the pharmacokinetics of CK in healthy Chinese individuals. Methods: Forty-two targeted variants in seven genes were genotyped in 54 participants using Sequenom MassARRAY system to investigate their association with major pharmacokinetic parameters of CK and its metabolite 20(S)-protopanaxadiol (PPD). Subsequently, molecular docking was simulated using the AutoDock Vina program. Results: ABCC4 rs1751034 TT and rs1189437 TT were associated with increased exposure of CK and decreased exposure of 20(S)-PPD, whereas CFTR rs4148688 heterozygous carriers had the lowest maximum concentration (Cmax) of CK. The area under the curve from zero to the time of the last quantifiable concentration (AUClast) of CK was decreased in NR1I2 rs1464602 and rs2472682 homozygous carriers, while Cmax was significantly reduced only in rs2472682. ABCC4 rs1151471 and CFTR rs2283054 influenced the pharmacokinetics of 20(S)-PPD. In addition, several variations in ABCC2, ABCC4, CFTR, and NR1I2 had minor effects on the pharmacokinetics of CK. Quality of the best homology model of multidrug resistance protein 4 (MRP4) was assessed, and the ligand interaction plot showed the mode of interaction of CK with different MRP4 residues. Conlusion: ABCC4 rs1751034 and rs1189437 affected the pharmacokinetics of both CK and 20(S)-PPD. NR1I2 rs1464602 and rs2472682 were only associated with the pharmacokinetics of CK. Thus, these hereditary variances could partly explain the interindividual differences in the pharmacokinetics of CK.
Minjae Kim;Jeong Hyun Lee;Leehi Joo;Boryeong Jeong;Seonok Kim;Sungwon Ham;Jihye Yun;NamKug Kim;Sae Rom Chung;Young Jun Choi;Jung Hwan Baek;Ji Ye Lee;Ji-hoon Kim
Korean Journal of Radiology
/
v.23
no.11
/
pp.1078-1088
/
2022
Objective: To develop and validate a model using radiomics features from apparent diffusion coefficient (ADC) map to diagnose local tumor recurrence in head and neck squamous cell carcinoma (HNSCC). Materials and Methods: This retrospective study included 285 patients (mean age ± standard deviation, 62 ± 12 years; 220 male, 77.2%), including 215 for training (n = 161) and internal validation (n = 54) and 70 others for external validation, with newly developed contrast-enhancing lesions at the primary cancer site on the surveillance MRI following definitive treatment of HNSCC between January 2014 and October 2019. Of the 215 and 70 patients, 127 and 34, respectively, had local tumor recurrence. Radiomics models using radiomics scores were created separately for T2-weighted imaging (T2WI), contrast-enhanced T1-weighted imaging (CE-T1WI), and ADC maps using non-zero coefficients from the least absolute shrinkage and selection operator in the training set. Receiver operating characteristic (ROC) analysis was used to evaluate the diagnostic performance of each radiomics score and known clinical parameter (age, sex, and clinical stage) in the internal and external validation sets. Results: Five radiomics features from T2WI, six from CE-T1WI, and nine from ADC maps were selected and used to develop the respective radiomics models. The area under ROC curve (AUROC) of ADC radiomics score was 0.76 (95% confidence interval [CI], 0.62-0.89) and 0.77 (95% CI, 0.65-0.88) in the internal and external validation sets, respectively. These were significantly higher than the AUROC values of T2WI (0.53 [95% CI, 0.40-0.67], p = 0.006), CE-T1WI (0.53 [95% CI, 0.40-0.67], p = 0.012), and clinical parameters (0.53 [95% CI, 0.39-0.67], p = 0.021) in the external validation set. Conclusion: The radiomics model using ADC maps exhibited higher diagnostic performance than those of the radiomics models using T2WI or CE-T1WI and clinical parameters in the diagnosis of local tumor recurrence in HNSCC following definitive treatment.
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