Transl Clin Pharmacol.  2017 Dec;25(4):196-201. 10.12793/tcp.2017.25.4.196.

Comparison of pharmacokinetics and safety of fixed-dose combination of SKI306X and aceclofenac versus separate tablets in healthy subjects

• Meng X
• Oh ES
• Park MS
• Kim D
• Kim JH
• Kim CO

• KMID: 2407002
• DOI: http://doi.org/10.12793/tcp.2017.25.4.196

Abstract

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 pharmacokinetics (PK) and safety of the FDC tablet with those of co-administered SKI306X and aceclofenac 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. T(max) and t(1/2) of aceclofenac of the FDC tablet were similar to those of aceclofenac co-administered with SKI306X (T(max): test 2.96 h and reference 2.14 h; t(1/2): test 3.46 h and reference 4.04 h). The geometric mean ratios (90% confidence intervals) of C(max) and AUC(last) (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) occurred 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.

Keyword

JOINS; aceclofenac; fixed-dose combination

MeSH Terms

Absorption
Healthy Volunteers*
Humans
Korea
Male
Osteoarthritis
Patient Compliance
Pharmacokinetics*
Tablets*
Tablets

Figure

• 

  Figure 1 Subject disposition. Abbreviations: Sequence T–R, a fixed-dose combination tablet of SKI306X 300 mg /aceclofeanc 100 mg once (treatment T) was administered first in period 1, then co-administration of 300 mg of SKI306X and 100 mg of aceclofenac as individual tablets once (treatment R) in period 2; Sequence R–T, treatment R first in period 1, then treatment T in period 2.

• 

  Figure 2 Mean (SD) plasma concentration-time profiles of aceclofenac (a: linear scale, b: semi-logarithmic scale).

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