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Effects of JOINS® on the pharmacokinetic profiles of aceclofenac in healthy Korean volunteers: an open-label, multiple-dose, one sequence, two-period study

Authors
 Dasohm Kim  ;  Eun Sil Oh  ;  Choon Ok Kim  ;  Chungam Choi  ;  Min Jung Chang  ;  Min Soo Park 
Citation
 Translational and Clinical Pharmacology, Vol.24(4) : 169-174, 2016 
Journal Title
 Translational and Clinical Pharmacology 
ISSN
 2289-0882 
Issue Date
2016
Keywords
aceclofenac ; JOINS ; drug interaction ; knee osteoarthritis ; pharmacokinetics
Abstract
JOINS, an herbal anti-arthritic drug, was developed for the treatment and pain relief of knee osteoarthritis. It was approved for use in Korea by the Ministry of Food and Drug Safety in 2001. The aim of this study was to investigate the effect of JOINS on the pharmacokinetic (PK) profiles of aceclofenac in healthy adults. A PK drug-drug interaction study was conducted in 61 healthy subjects by using an open-label, multiple-dose, one sequence, two-period design. Blood samples were collected for plasma concentrations of aceclofenac during the reference period (aceclofenac 100 mg alone) and interaction period (aceclofenac 100 mg + JOINS 300 mg). The area under the curve within a dosing interval (τ) at steady state (AUCτ,ss) and the Cmax at steady state (Cmax,ss) of aceclofenac were analyzed by a non-compartment model using the Phoenix® WinNonlin® software version 6.3 (Pharsight, Mountain View, CA, USA). The 90% CIs of the geometric mean ratios (GMRs) of the AUCτ,ss of aceclofenac with JOINS to without JOINS (D4/D3 and D11/D3) were 0.9593?1.0130 and 0.9745?1.0291, respectively, and the corresponding values for the Cmax,ss of aceclofenac with JOINS to without JOINS (D4/D3 and D11/D3) were 0.8578?0.9795 and 0.8510?0.9717. Aceclofenac alone or co-administered with JOINS was safe and well tolerated with no serious adverse drug reactions or significant differences in the severity of adverse events (AEs) between the two treatment groups. We conclude that co-administration of aceclofenac with JOINS does not influence the PK and safety profiles of aceclofenac.
Files in This Item:
T201605438.pdf Download
DOI
10.12793/tcp.2016.24.4.169
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Pediatrics (소아청소년과학교실) > 1. Journal Papers
Yonsei Authors
Kim, Choon Ok(김춘옥) ORCID logo https://orcid.org/0000-0002-2319-1108
Park, Min Soo(박민수) ORCID logo https://orcid.org/0000-0002-4395-9938
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URI
https://ir.ymlib.yonsei.ac.kr/handle/22282913/152823
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