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KMID : 1038020170250040196
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Translational and Clinical Pharmacology
2017 Volume.25 No. 4 p.196 ~ p.201
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Comparison of pharmacokinetics and safety of fixed-dose combination of SKI306X and aceclofenac versus separate tablets in healthy subjects
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Meng Xue
Oh Eun-Sil
Park Min-Soo
Kim Da-Sohm
Kim Jeong-Hoon
Kim Choon-Ok
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Abstract
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JOINS (SKI306X) is an herbal anti-arthritic medicine that is widely used with aceclofenac for treating osteoarthritis in Korea. A fixed-dose combination (FDC) tablet containing SKI306X and aceclofenac was developed to improve patient compliance. This study aimed to compare the phar-macokinetics (PK) and safety of the FDC tablet with those of co-administered SKI306X and ace-clofenac in healthy subjects. In this randomized, open-label, two-way crossover, single-dose study, the FDC tablet (SKI306X 300 mg/aceclofenac 100 mg) (test) was given or co-administration of 300 mg of SKI306X and 100 mg of aceclofenac (reference) was performed followed by a 7-day wash-out period. Blood samples were collected before and after drug administration to evaluate aceclofenac PK parameters, and safety was assessed throughout the study. A total of 54 healthy male subjects were enrolled in and completed the study. Tmax and t1/2 of aceclofenac of the FDC tablet were similar to those of aceclofenac co-administered with SKI306X (Tmax: test 2.96 h and reference 2.14 h; t1/2: test 3.46 h and reference 4.04 h). The geometric mean ratios (90% confidence intervals) of Cmax and AUClast (T/R) were 0.85 (0.81 to 0.91) and 1.03 (1.01 to 1.06) respectively; these results were within the predefined range (0.8 to 1.25). There was only one drug-related adverse event (dizziness) oc-curred after administration of the FDC tablet; however, it was mild in severity and resolved without any complications. The FDC tablet was well tolerated and exhibited an absorption rate and extent comparable to those of SKI306X and aceclofenac administered simultaneously.
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KEYWORD
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JOINS, aceclofenac, fixed-dose combination
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