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2013 (v.21 no.2)

The Journal of Korean Society for Clinical Pharmacology and Therapeutics

Korean Society for Clinical Pharmacology and Therapeutics
Semiannual
ISSN: 1225-5467

  • Pharmacokinetics of T-614 after Single Oral Administration in Healthy Korean Volunteers

    Dongseong Shin, Bo-Hyung Kim, Jung-Ryul Kim, Kyoung Soo Lim, In-Jin Jang, Sang-Goo Shin, Kyung-Sang Yu

    J Korean Soc Clin Pharmacol Ther | v.21, no.2, pp.150-158, Dec, 2013

    Abstract

    Background: Iguratimod is a new type of disease modifying anti-rheumatic drug, which reduced the
    production of inflammatory cytokines. The purpose of this study was to evaluate pharmacokinetic
    characteristics and safety profiles of iguratimod after a single oral administration in healthy Korean
    volunteers.
    Methods: A randomized, double-blind, placebo-controlled, parallel group, single oral dose study was
    conducted in 24 healthy male volunteers. Three groups of eight subjects each received 25 mg, 50 mg, or
    100 mg dosage, respectively. Two subjects in each dose group were administered matching placebo.
    Plasma concentrations of iguratimod were measured till 72 hours after drug administration. Tolerability
    was evaluated by monitoring adverse events, clinical laboratory tests, and 12-lead electrocardiograms.
    Results: The mean area under the concentration-time curve from 0 to 72 hours (AUClast) were 11.9, 25.2,
    and 51.8 mg × h/L and the maximum plasma concentration (Cmax) were 1.15, 2.33, and 4.78 mg/L in 25,
    50 and 100 mg dose groups, respectively. All doses of iguratimod were well tolerated without serious
    adverse events or clinically meaningful changes.
    Conclusion: Cmax and AUClast values of iguratimod proportionally increased with incremental dose.
    Iguratimod was generally safe and well tolerated.

    Keyword

    Iguratimod, Pharmacokinetics, Korean