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８名健康男性志愿者单剂量交叉口服１００ｍｇ受试双氯芬酸钠缓释片、扶他林或ＶｏｌｔａｒｅｎＳＲ１００后，Ｔｍａｘ分别为２．４±１．０、２．１±０．５和４．４±１．８ｈ；Ｃｍａｘ分别为６０２．６±９２．８、３３３７．６±１０８８．２ ７６１．０±３４２．０ｎｇ／ｍｌ；ＭＲＴ分别为１３．２±４．８、２．９±０．８和７．９±１．９ｈ；ＡＵＣ０分别为４８６６．２±６４４．６、５３１４．３±５３４．３和４８２９．１±５８２．８ｎｇ／（ｍｌ－１·ｈ）；双氯芬酸钠缓释片和ＶｏｌｔａｒｅｎＳＲ１００相对于扶他林的生物利用度分别为８８．３±１３．２％和８６．３±１２．６％。另８名志愿者交叉口服受试双氯芬酸钠缓释片（１００ｍｇ，ｐｄ）和扶他林（５０ｍｇ，ｂｉｄ〕，连服５天。Ｃｍａｘ分别为５９３．９±１３４．１、１２４７．８±５２７．５ｎｇ／ｍｌ，峰谷波动率（ＰＴＦ）分别为３．３±１．２、５．３±２．１。本研究将为新型双氯芬酸钠缓释片的临床应用提供依据。
Tmax of 2.4 ± 1.0, 2.1 ± 0.5 and 4.4 ± 1.8 h after oral administration of 100 mg diclofenac sodium sustained-release tablets, fradarine or VoltarenSR100 in a single dose of 8 healthy male volunteers ; Cmax were 602.6 ± 92.8, 3337.6 ± 1088.2 761.0 ± 342.0 ng / ml; MRT was 13.2 ± 4.8, 2.9 ± 0.8 and 7, respectively. 9 ± 1.9h; AUC0 4866.2 ± 644.6,5314.3 ± 534.3 and 4829.1 ± 582.8ng / (ml-1 · h), respectively; diclofenac sodium sustained-release tablets and VoltarenSR100 were The bioavailability of pentaphyllum was 88.3 ± 13.2% and 86.3 ± 12.6%, respectively. The other 8 volunteers were given oral diclofenac sodium sustained-release tablets (100mg, pd) and pentralin (50mg, bid) for 5 consecutive days with Cmax of 593.9 ± 134.1,1247.8 ± 527.5ng / Ml and peak to valley volatility (PTF) were 3.3 ± 1.2 and 5.3 ± 2.1, respectively.This study will provide the basis for the clinical application of new diclofenac sodium sustained-release tablets.