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PO1-11-22

Pharmacokinetics and Safety of CK-30 in Comparison with Red Ginseng Extracts in Healthy Subjects

[Speaker] Eunwoo Kim:1
[Co-author] Yun Kim:1, Hong-Keun Chung:2, Sang Chun Ji:2, Byung-Ryul Han:2, Sunyong Lee:2, Seunghee Ham:2, Kyung-Sang Yu:1, In-Jin Jang:1, Seunghwan Lee:1
1:Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, Seoul, Korea, 2:MGINBIO., Korea

Background
CK-30 contains purified ginsenosides Rg1, Rb1, Rg3 and compound K from fermented ginseng. CK-30 is expected to increase the systemic absorption of compound K compared to ginseng. The aim of this study was to compare the pharmacokinetic and safety profiles of CK-30 to the red ginseng extracts.

Methods
A randomized, open-label, two-treatment, two-period, two-sequence, crossover study was conducted in healthy males. The subjects received a single oral dose of CK-30 600 mg (compound K 15mg, daily oral dose) or the red ginseng extracts 2.94 g (daily oral dose) in each period, with a 7-days washout period. Serial blood samples were obtained up to 24 hours after dosing and the plasma concentrations of compound K were measured using HPLC-MS/MS. The pharmacokinetic parameters including maximum plasma concentration (Cmax) and area under the plasma concentration-time curve from time zero to time of last measurable concentration (AUClast) were calculated by the non-compartmental method. Safety profiles were evaluated by adverse events, vital sign, physical examination, ECG examination and clinical laboratory tests. In addition, metagenomic analysis was performed to evaluate changes in intestinal microorganism strains according to each treatment.

Results
A total of 22 subjects completed the study. The median time to reach Cmax of compound K after administration of CK-30 was 3.0 hours, whereas the corresponding value of red ginseng extracts was 10.0 hours. Compared with red ginseng extracts, CK-30 resulted in a relatively higher systemic exposure of compound K, with a 118.3-fold increase in Cmax and a 135.1-fold increase in AUClast. Both CK-30 and red ginseng extracts were well tolerated and no serious adverse events were observed. Metagenomic analysis showed that both CK-30 and red ginseng extracts increased intestinal microbial diversity in a similar pattern.

Conclusion
The systemic exposure of compound K was significantly higher after administration of CK-30 compared with the red ginseng extracts, and both treatments were well tolerated.
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