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《Journal of The Fourth Military Medical University》 2005-13
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Pharmacokinetics and relative bioequi-valence of sustain-released nefopam hydrochloride tablets in healthy volunteers

CHEN Ping-Jun~1, WEN Ai-Dong~1, LUO Xiao-Xing~2, ZHAO Lei~1, YANG Zhi-Fu~1, WU Yin~1, SHEN Tong~1, XIE Li~1 ~1Department of Pharmacy, Xijing Hospital, ~2Department of Pharmacology, School of Pharmacology, Fourth Military Medical University, Xi'an 710033, China  
AIM: To investigate the pharmacokinetics and the bioequivalence of the nefopam hydrochloride sustain-released tablets in 20 healthy male volunteers. METHODS: Twenty volunteers were randomly distributed into two groups by an open, randomized two-period crossover with seven days washout interval. A single or multi oral doses were given to the volunteers. Nefopam hydrochloride concentration was assayed by the HPLC-MS. RESULTS: The standard curve was linear within the range of 2 and 150 μg/L for nefopam hydrochloride, the correlation coefficient of calibration curve was 0.9998 and the minimum limit of detection in plasma was 2 μg/L. The pharmacokinetics parameters of sustain-released tablets or common tablets obtained from single oral dose study were as following: ρ_(max) (72±18) and (105±25) μg/L, T_(peak) (5.1±0.6), (2.1±0.7)h, respectively; AUC_((0-24 h)) (907±340) and ((865±)287) μg·h/L. The steady-state pharmacokinetics parameters: AUC~(SS)_((0-24 h))(1308±313)and(504±109)μg·h/L, ρ_(max)(101±20) and (114±28)μg/L, and ρ_(min)(29±13) and (20±12)μg/L. CONCLUSION: The results of the present study indicate that the sustain-released tablets and common tablets are the bioequivalent (P0.05) in healthy volunteers.
【CateGory Index】: R96
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