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김종국(Chong Kook Kim),이사원(Sa Won Lee),최한곤(Han Gon Choi),고종호(Zhong Gao Gao),이미경(Mi Kyung Lee),김인숙(In Sook Kim) 한국응용약물학회 1998 Biomolecules & Therapeutics(구 응용약물학회지) Vol.6 No.2
The bioequivalence of two clarithromycin products was evaluated with 16 normal male volunteers (age 23-28 yr, body weight 57.5-75.5 kg) following single oral dose. Test product was ReYon Clarithromycin tablets (ReYon Pharm. Corp., Korea) and reference product was Klaricid^R tablets (Abbott Korea). Both products contain 250 mg of clarithromycin. One tablet of the test or the reference product was administered to the volunteers, respectively, by randomized two period cross-over study (2 x 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 0.03 ㎍/ml using 100 ㎕ 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) (AUC_(0→24h)) (8.10 ±1.26 vs 8.22 ±1.62 ,㎍/ml), AUC from time zero to infinite (AUC_(0→∞)) (8.61 ±1.28 vs 8.84 ±1.71 ㎍ ·hr/ml), maximum plasma concentration (C_(max)) (0.87 ±0.22 vs 0.88 ±0.19 ㎍/ml) and time to maximum plasma concentration (T_max) (2.69 ±0.48 vs 2.56 ±0.51 hr). The differences of mean AUC _(0→24h), C_(max) and T_(max) between the two products (1.44, 1.39, and 4.65%, respectively) were less than 20%. The power (1-β) and treatment difference (△) for AUC _(0→24h), and C_(max) were more than 0.8 and less than 0.2, respectively. Although the power for T_(max) was under 0.8, T_(max) 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 Klaricid^R tablets. Therefore, two products are bioequivalent based on the current results.
김종국(Chong Kook Kim),이사원(Sa Won Lee),최한곤(Han Gon Choi),고종호(Zhong Gao Gao),이미경(Mi Kyung Lee),김인숙(In Sook Kim) 한국응용약물학회 1998 Biomolecules & Therapeutics(구 응용약물학회지) Vol.6 No.3
The bioequivalence of two nilvadipine products was evaluated in 16 normal male volunteers (age 22-32 yr, body weight 57-80 kg) following sigle oral dose. Test product was Overcal^R tablet (Choong-Wae Pharm. Corp., Korea) and reference product was Nivadil^R tablet (Hyundai Pharm. Corp., Korea). Both products contain 4 mg of nilvadipine. One tablet of the test or the reference product was administered to the volunteers, respectively, by randomized two period cross-over study (2 x 2 Latin square method). The determination of nilvadipine was accomplished using a validated capillary column GC with electron-capture detection. As a result of the assay validation, the quantification of nilvadipine in human plasma by this technique was possible down to 0.5 ng/ml using 1 ml of plasma. Absolute overall recovery from five replicate analyses of nilvadipine-spiked sample were 88.4 ±10.24% (mean±S.D.) for human plasma of 10 ng/ml. The coefficients of variation (C.V.) were less than 20% and the actual concentration of nilvadipine measured by GC ranged from 80 to 99% in all plasma. 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 from time zero to 8 hr (AUC_(0→8hr)) (22.8 ±5.90 vs 22.2±6.10 ng ·hr/ml), maximum plasma concentration (C_(max)) (10.0 ±2.85 vs 9.3 ±3.28 ng/ml) and time to reach maximum plasma concentration (T_(max)) (1.2 ±0.31 vs 1.3 ±0.47 hr). The differences of mean AUC_(0→8hr), C_(max) and T_(max) between the two products (2.25, 7.65, and 10.30%, respectively) were less than 20%. The power (1-β) and treatment difference (△) for AUC_(0→8hr), and C_(max) were more than 0.8 and less than 0.2, respectively. Although the power for Tmax was under 0.8, T_(max) of the two products was not significantly different from each .other (p>0.05). These results suggest that the bioavailability of Overcal tablet is not significantly different from that of Nivadil tablet. Therefore, two products are bioequivalent based on the current results.
아세트아미노펜 액상좌제의 제조 및 생물학적 동등성 평가
김인숙(In Sook Kim),김종국(Chong Kook Kim),최한곤(Han Gon Choi),이사원(Sa Won Lee),고종호(Zhong Gao Gao),임수정(Soo Jeong Lim),박영준(Young Joon Park),이미경(Mi Kyung Lee) 한국응용약물학회 1998 Biomolecules & Therapeutics(구 응용약물학회지) Vol.6 No.2
A novel in situ-gelling and mucoadhesive acetaminophen liquid suppository was developed to improve the patient compliance of conventional solid suppository. In this study, acetaminophen liquid suppository, Likipen^R [acetaminophen/Poloxamer 407/Poloxamer 188/sodium alginate (5/15/19/0.6%)] with gelation temperature at 30-36℃ and suitable gel strength and bioadhesive force, dissolution pattern similar to conventional solid type suppository, Suspen^R was developed. Furthermore, the bioequivalence of two acetaminophen products was evaluated in 16 normal male volunteers (age 22-27 yr, body weight 56-72 kg) following sigle rectal administration. Test product was Likipen^R suppository (Dong-Wha Pharm. Corp., Korea) and reference product was Suspen^R suppository (Hanmi Phann. Corp., Korea). Both products contain 125 mg of acetaminophen. Four Suppositories of the test and the reference product were administered to the volunteers, respectively, by randomized two period cross-over study (2 x 2 Latin square method). The determination of acetaminophen was accomplished using HPLC. 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) (AUC_(0→24h)) (30.14±8.64 vs 27.98±6.53 ㎍ ·h/ml), maximum plasma concenhation (C_(max)) (3.29 ±0.87 vs 3.60 ±0.66 ㎍/ml) and time to maximum plasma concentration (T_(max)) (2.91 ±0.55 vs 2.69 ±0.60 h). The differences of mean AUC_(0→24h), C_(max) and T_(max) between the two products (7.18%, 9.58% and 7.53%, respectively) were less than 20%. The power (1-β) and treatment difference (△) for AUC_(0 →24h), C_(max) and T_(max) were more than 0.8 and less than 0.2, respectively at α= 0.1. The confidence limits for AUC_(0→24h), C_(max) and T_(max) (-0.81∼13.55 %, -1.56 ∼17.60 and -3.81∼18.87%, respectively) were less than ±20% at α=0.1. These results suggest that the bioavailability of Likipen^R suppository is not significantly different from that of Suspen^R suppository. Therefore, two products are bioequivalent based on the current results.
사이클로스포린 A 경질캅셀제에 대한 생물학적 동등성 평가
김종국(Chong Kook Kim),이은진(Eun Jin Lee),박준규(Jun Kyu Park),이미경(Mi Kyung Lee),신희종(Hee Jong Shin),최한곤(Han Gon Choi),이사원(Sa Won Lee),임수정(Soo Jeong Lim),고종호(Zhong Gao Gao),김인숙(In Sook Kim) 한국응용약물학회 1998 Biomolecules & Therapeutics(구 응용약물학회지) Vol.6 No.3
The bioequivalence of two cyclosporin A products was evaluated in 26 normal male volunteers (age 25∼33 yr, body weight 56∼84 kg) following single oral administration. Test product was a hard capsule containing the granule of cyclosporin A (Chong Kun Dang Corp., Korea) and reference product, Sandimmun^R was a soft capsule containing surfactant, oil, alcohol and cyclosporin A (Sandoz, Swiss). Both products contain 100 mg of cyclosporin A. Four capsules of the test and the reference product were administered to the volunteers, respectively, by randomized two period cross-over study (2 x 2 Latin square method). Average drug concentrations at each sampling time and pharmacokinetic parameters were not significantly different between two products (p>0.05); the area under the concentration-time curve to last sampling time (24 hr) (AUC_(0→24)) (5034.8 ±1760.6 vs 4635.4 ±1158.9 ng ·h/ml), maximum plasma concentration (C_(max)) (1002.7 ±353.1 vs 980. 4 ±171.7 ng/ml), and mean residence time (MRT) (6.16 ±0.81 vs 5.64 ±0.50 h). The differences of mean AUC_(0→24), C_(max) T_(max) and MRT between the two products (7.93, 2.22, 16 and 8.39%, respectively) were less than 20% given as a guideline. The power (1-β) and treatment difference (△) for AUC_(0→24), C_(max) and MRT were more than 0.8 and less than 0.2, respectively. Although T_(max) of the two products was significantly different each other (p< 0.05), T_(max) might be an insignificant parameter because cyclosporin A generally requires long-term administration. From these results, the two products are bioequivalent.