Effects of JOINS® on the pharmacokinetic profiles of aceclofenac in healthy Korean volunteers: an open-label, multiple-dose, one sequence, two-period study.
10.12793/tcp.2016.24.4.169
- Author:
Dasohm KIM
1
;
Eun Sil OH
;
Choon Ok KIM
;
Chungam CHOI
;
Min Jung CHANG
;
Min Soo PARK
Author Information
1. Department of Pharmaceutical Medicine and Regulatory Sciences, Colleges of Medicine and Pharmacy, Yonsei University, Incheon 21983, Republic of Korea. minspark@yuhs.ac
- Publication Type:Original Article
- Keywords:
aceclofenac;
JOINS;
drug interaction;
knee osteoarthritis;
pharmacokinetics
- MeSH:
Adult;
Drug Interactions;
Drug-Related Side Effects and Adverse Reactions;
Healthy Volunteers;
Humans;
Korea;
Osteoarthritis, Knee;
Pharmacokinetics;
Plasma;
Volunteers*
- From:Translational and Clinical Pharmacology
2016;24(4):169-174
- CountryRepublic of Korea
- Language:English
-
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 (AUC(τ,ss)) and the C(max) at steady state (C(max,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 AUC(τ,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 C(max,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.
