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학술연구/단체지원/교육 등 연구자 활동을 지속하도록 DBpia가 지원하고 있어요.
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초록· 키워드
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The aim of this study was to evaluate the pharmacokinetic parameters of two risedronate preparations. The clinical assessment was conducted on 46 healthy volunteers who received one tablet (Risedronate sodium 35 mg/tablet) in the fasting state, in a randomized balanced 2×2 cross-over study design. After dosing of one tablet containing 35 mg risedronate sodium, blood samples were collected serially for a period of 48 hours. Plasma was analyzed for risedronate by using LC/MS/MS assay method. The analysis system was validated in specificity, accuracy, precision, and linearity. AUCt, (the area under the plasma concentration-time curve from the zero-time to 48 hr) was calculated through the trapezoidal rule. Cmax (maximum plasma drug concentration) were compiled from the plasma risedronate concentrationtime
data of each volunteer. No significant sequence effect was found for the pharmacokinetic parameters indicating that the cross-over design was properly performed. The 90 % - Confidence intervals of the AUCt ratio and the Cmax were from log 0.8752 to log 1.1888 and log 0.8457 to log 1.1478, respectively. These values were within the acceptable intervals between 0.80 and 1.25. Therefore, this study demonstrated that no statistically significant difference was identified with respect to the rate and extent of absorption.
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참고문헌 (15)
참고문헌 신청
Bekker P / 1996 / Risedronate dose response in prevention of early postmenopausal bone loss / J Bone Miner Res 11 (3) : S347 ~
Delmas PD / 1997 / Bisphosphonate risedronate prevents bone loss in women with artificial menopause due to chemotherapy of breast cancer: a double-blind, placebo-controlled s
Dunn CJ / 2001 / Risedronate: a review of its pharmacolo gical properties and clinical use in resorptive bone disease / Drugs 61 (5) : 685 ~ 712
Fogelman I / 1986 / Absorption of oral diphosphonate in normal subjects / Clin Endocrinol 24 (1) : 57 ~ 62
Lin J / 1996 / Bisphosphonates: a review of their pharmacokinetic properties / Bone 18 (2) : 75 ~ 85
Delmas PD / 1997 / Bisphosphonate risedronate prevents bone loss in women with artificial menopause due to chemotherapy of breast cancer: a double-blind, placebo-controlled s
Dunn CJ / 2001 / Risedronate: a review of its pharmacolo gical properties and clinical use in resorptive bone disease / Drugs 61 (5) : 685 ~ 712
Fogelman I / 1986 / Absorption of oral diphosphonate in normal subjects / Clin Endocrinol 24 (1) : 57 ~ 62
Lin J / 1996 / Bisphosphonates: a review of their pharmacokinetic properties / Bone 18 (2) : 75 ~ 85
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