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

Dasohm Kim, Eun Sil Oh, Choon Ok Kim, Chungam Choi, Min Jung Chang, Min Soo Park

Research output: Contribution to journalArticle

1 Citation (Scopus)

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.

Original languageEnglish
Pages (from-to)169-174
Number of pages6
JournalTranslational and Clinical Pharmacology
Volume24
Issue number4
DOIs
Publication statusPublished - 2016 Jan 1

Fingerprint

Healthy Volunteers
Pharmacokinetics
Area Under Curve
aceclofenac
Pharmaceutical Preparations
Food Safety
Knee Osteoarthritis
Korea
Drug-Related Side Effects and Adverse Reactions
Drug Interactions
Arthritis
Software
Safety
Pain
Therapeutics

All Science Journal Classification (ASJC) codes

  • Pharmacology (medical)

Cite this

@article{873d1a9a56d9437c86f0ad315eee3efc,
title = "Effects of joins{\circledR} on the pharmacokinetic profiles of aceclofenac in healthy Korean volunteers: An open-label, multiple-dose, one sequence, two-period study",
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{\circledR} WinNonlin{\circledR} 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.",
author = "Dasohm Kim and Oh, {Eun Sil} and Kim, {Choon Ok} and Chungam Choi and Chang, {Min Jung} and Park, {Min Soo}",
year = "2016",
month = "1",
day = "1",
doi = "10.12793/tcp.2016.24.4.169",
language = "English",
volume = "24",
pages = "169--174",
journal = "Translational and Clinical Pharmacology",
issn = "2289-0882",
publisher = "Korean Society for Clinical Pharmacology and Therapeutics",
number = "4",

}

Effects of joins® on the pharmacokinetic profiles of aceclofenac in healthy Korean volunteers : An open-label, multiple-dose, one sequence, two-period study. / Kim, Dasohm; Oh, Eun Sil; Kim, Choon Ok; Choi, Chungam; Chang, Min Jung; Park, Min Soo.

In: Translational and Clinical Pharmacology, Vol. 24, No. 4, 01.01.2016, p. 169-174.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Effects of joins® on the pharmacokinetic profiles of aceclofenac in healthy Korean volunteers

T2 - An open-label, multiple-dose, one sequence, two-period study

AU - Kim, Dasohm

AU - Oh, Eun Sil

AU - Kim, Choon Ok

AU - Choi, Chungam

AU - Chang, Min Jung

AU - Park, Min Soo

PY - 2016/1/1

Y1 - 2016/1/1

N2 - 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.

AB - 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.

UR - http://www.scopus.com/inward/record.url?scp=85019741006&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85019741006&partnerID=8YFLogxK

U2 - 10.12793/tcp.2016.24.4.169

DO - 10.12793/tcp.2016.24.4.169

M3 - Article

AN - SCOPUS:85019741006

VL - 24

SP - 169

EP - 174

JO - Translational and Clinical Pharmacology

JF - Translational and Clinical Pharmacology

SN - 2289-0882

IS - 4

ER -