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Original Research

Multiple-dose pharmacokinetics of fesoterodine sustained-release in healthy Korean volunteers

Dongseong Shin, Kwang-Hee Shin, SeungHwan Lee, Kyoung Soo Lim, Joo-Youn Cho, In-Jin Jang, Sang-Goo Shin and Kyung-Sang Yu

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Volume 50 p. 722 - 728

Abstract

International Journal of Clinical Pharmacology and Therapeutics, Vol. 50 – No. 10/2012 (722-728)

Multiple-dose pharmacokinetics of fesoterodine sustained-release in healthy Korean volunteers

Dongseong Shin, Kwang-Hee Shin, SeungHwan Lee, Kyoung Soo Lim, Joo-Youn Cho, In-Jin Jang, Sang-Goo Shin and Kyung-Sang Yu

Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, Seoul, Korea
Objective: Fesoterodine is a pro-drug of the active metabolite 5-hydroxymethyl tolterodine (5-HMT), a muscarinic receptor antagonist. This study aimed to evaluate the safety profile and pharmacokinetic characteristics of multiple oral doses of sustained-release fesoterodine (fesoterodine SR) in healthy Korean males. Methods: A randomized, double-blind, placebo-controlled, multiple-dose study with two oral doses (4 mg and 8 mg) was conducted in healthy Korean male participants. The study drug was administered once daily for 5 days. The plasma concentration of 5-HMT was measured up to 72 hours after the last drug administration. The CYP2D6 genotype was analyzed using polymerase chain reaction (PCR) methods to assess the effect of genetic polymorphisms on the pharmacokinetic parameters. Results: 20 participants completed the study. The mean (SD) areas under the plasma concentration-time curves during the dosing interval (AUC_τ) of the 4 mg and 8 mg dose groups were 26.1 (8.0) and 64.2 (30.5) μg∙h/ml and the mean peak concentrations (C_max) were 2.6 (0.7) and 6.0 (2.0) μg/ml, respectively, at steady-state. The mean AUC_τ and C_max of 5-HMT increased in approximately the same proportion as the dose increased. Fesoterodine SR was well tolerated without any serious adverse events or abnormal clinical laboratory findings. Conclusion: Systemic 5-HMT exposure showed dose-proportional characteristics in the 4 mg to 8 mg dose range in healthy Korean males. Thus, 4 mg or 8 mg doses of fesoterodine SR taken once-daily were tolerable in healthy Korean males.Correspondence to:
Kyung-Sang Yu, MD, PhD
Department of Clinical Pharmacology and Therapeutics Seoul
National University College of Medicine and Hospital Seoul
101 Daehangno, Jongno-gu
Seoul 110-744, Korea
Email: [email protected]

Bioavailability Section

Comparative pharmacokinetics of Theracurmin, a highly bioavailable curcumin, in healthy adult subjects 

Hyewon Chung, Seo Hyun Yoon, Joo-Youn Cho, Hee Kyung Yeo, Dongseong Shin, and Ji-Young Park

Volume 59 (2021) p. 684 - 690

Abstract

International Journal of Clinical Pharmacology and Therapeutics, Vol. 59 – No. 10/2021 (684-690)

Comparative pharmacokinetics of Theracurmin, a highly bioavailable curcumin, in healthy adult subjects 

Hyewon Chung¹, Seo Hyun Yoon², Joo-Youn Cho²#³, Hee Kyung Yeo⁴, Dongseong Shin⁶*, and Ji-Young Park⁵*

¹Department of Clinical Pharmacology and Toxicology, Korea University Guro Hospital, ²Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, ³Department of Biomedical Sciences, Seoul National University College of Medicine, ⁴R&D Center, Handok Inc., ⁵Department of Clinical Pharmacology and Toxicology, Korea University College of Medicine, Korea University Anam Hospital, Seoul, and ⁶Department of Pharmacology, Gachon University College of Medicine, Gil Medical Center, Incheon, Korea
Objective: Theracurmin is a submicron dispersed formulation of curcumin, which was developed to increase the bioavailability of curcumin. This study aimed to compare the pharmacokinetics of curcumin administered as two Theracurmin powder products and unformulated curcumin powder.
Materials and methods: This randomized, three-treatment, six-sequence, and three-period crossover study enrolled 24 healthy subjects. Blood sampling was done until 12 hours after the administration of Theracurmin and curcumin powder to assess pharmacokinetics using a non-compartmental method. The plasma concentration of curcumin was determined using high-performance liquid chromatography coupled with tandem mass spectrometry.
Results: The median time to reach the maximum concentration was 1.5 – 3 hours for Theracurmin and 8 hours for curcumin powder. The two Theracurmin products showed systemic exposure profiles that were comparable to each other. The exposure ratio of Theracurmin to curcumin powder was 18.4 – 20.5 for the maximum plasma concentration and 35.9 – 42.6 for the area under the concentration-time curve from dosing to the last measurable time.
Conclusion: In conclusion, this study showed similar systemic exposure between the two Theracurmin products. The absorption of curcumin after the administration of Theracurmin was significantly enhanced compared with curcumin powder.

*These authors contributed equally to this work as corresponding authors.Correspondence to:
 Ji-Young Park, MD, PhD,  Professor 
Department of Clinical Pharmacology and Toxicology
Korea University College of Medicine
Korea University Anam Hospital
Seoul, Korea
Email: [email protected]

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