PMID- 29375375
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20220409
IS  - 1663-9812 (Print)
IS  - 1663-9812 (Electronic)
IS  - 1663-9812 (Linking)
VI  - 8
DP  - 2017
TI  - Single- and Multiple-Dose Trials to Determine the Pharmacokinetics, Safety, 
      Tolerability, and Sex Effect of Oral Ginsenoside Compound K in Healthy Chinese 
      Volunteers.
PG  - 965
LID - 10.3389/fphar.2017.00965 [doi]
LID - 965
AB  - Background and objectives: Ginsenoside compound K (CK) is a candidate drug for 
      rheumatoid arthritis therapy. The objective of this study was to investigate the 
      pharmacokinetic properties, safety and tolerability of CK. Methods: In 
      randomized, double-blind trials, 76 healthy Chinese subjects received 1 of 7 
      single oral doses (25, 50, 100, 200, 400, 600, 800 mg) of CK or placebo under 
      fasting condition, and another 36 subjects received repeated oral doses (100, 
      200, or 400 mg) of CK or placebo for up to 9 days a week after a corresponding 
      single dose, after breakfast. Both sexes were equally represented in the two 
      trials. Pharmacokinetic parameters of CK and its metabolite 20(S)-protopanaxadiol 
      (PPD) were calculated and statistically analyzed according to the plasma 
      concentration data. Tolerability was evaluated by adverse events (AEs) and 
      laboratory examinations. Results: The range of time to maximum concentration 
      (T(max)) was 1.5-6.0 h, with a linear increase in the exposure of CK over the 
      dose range of 100-400 mg. Steady state was reached after the 7th administration, 
      and the accumulation index range was 2.60-2.78. Sex differences were 
      characterized by a higher exposure in females than males with the single 
      administration after breakfast. In addition, no severe AEs were observed. 
      Conclusion: CK was safe and well-tolerated over the treatment period. The sex- 
      and food-related impacts on CK pharmacokinetics need further investigations to be 
      validated. (Registration number: ChiCTR-TRC-14004824 and ChiCTR-IPR-15006107, 
      http://www.chictr.org.cn/index.aspx).
FAU - Chen, Lulu
AU  - Chen L
AD  - Department of Clinical Pharmacology, Xiangya Hospital, Central South University, 
      Changsha, China.
AD  - Institute of Clinical Pharmacology, Central South University, Changsha, China.
FAU - Zhou, Luping
AU  - Zhou L
AD  - Department of Clinical Pharmacology, Xiangya Hospital, Central South University, 
      Changsha, China.
AD  - Institute of Clinical Pharmacology, Central South University, Changsha, China.
FAU - Huang, Jie
AU  - Huang J
AD  - Center of Clinical Pharmacology, Third Xiangya Hospital, Central South 
      University, Changsha, China.
FAU - Wang, Yaqin
AU  - Wang Y
AD  - Department of Clinical Pharmacology, Xiangya Hospital, Central South University, 
      Changsha, China.
AD  - Institute of Clinical Pharmacology, Central South University, Changsha, China.
FAU - Yang, Guoping
AU  - Yang G
AD  - Center of Clinical Pharmacology, Third Xiangya Hospital, Central South 
      University, Changsha, China.
FAU - Tan, Zhirong
AU  - Tan Z
AD  - Department of Clinical Pharmacology, Xiangya Hospital, Central South University, 
      Changsha, China.
AD  - Institute of Clinical Pharmacology, Central South University, Changsha, China.
FAU - Wang, Yicheng
AU  - Wang Y
AD  - Department of Clinical Pharmacology, Xiangya Hospital, Central South University, 
      Changsha, China.
AD  - Institute of Clinical Pharmacology, Central South University, Changsha, China.
FAU - Zhou, Gan
AU  - Zhou G
AD  - Department of Clinical Pharmacology, Xiangya Hospital, Central South University, 
      Changsha, China.
AD  - Institute of Clinical Pharmacology, Central South University, Changsha, China.
FAU - Liao, Jianwei
AU  - Liao J
AD  - Department of Clinical Pharmacology, Xiangya Hospital, Central South University, 
      Changsha, China.
AD  - Institute of Clinical Pharmacology, Central South University, Changsha, China.
FAU - Ouyang, Dongsheng
AU  - Ouyang D
AD  - Department of Clinical Pharmacology, Xiangya Hospital, Central South University, 
      Changsha, China.
AD  - Institute of Clinical Pharmacology, Central South University, Changsha, China.
AD  - Hunan Key Laboratory for Bioanalysis of Complex Matrix Samples, Changsha, China.
LA  - eng
PT  - Journal Article
DEP - 20180111
PL  - Switzerland
TA  - Front Pharmacol
JT  - Frontiers in pharmacology
JID - 101548923
PMC - PMC5769417
OTO - NOTNLM
OT  - ginsenoside compound K
OT  - pharmacokinetics
OT  - rheumatoid arthritis
OT  - sex factor
OT  - tolerability
EDAT- 2018/01/30 06:00
MHDA- 2018/01/30 06:01
PMCR- 2018/01/11
CRDT- 2018/01/30 06:00
PHST- 2017/10/26 00:00 [received]
PHST- 2017/12/19 00:00 [accepted]
PHST- 2018/01/30 06:00 [entrez]
PHST- 2018/01/30 06:00 [pubmed]
PHST- 2018/01/30 06:01 [medline]
PHST- 2018/01/11 00:00 [pmc-release]
AID - 10.3389/fphar.2017.00965 [doi]
PST - epublish
SO  - Front Pharmacol. 2018 Jan 11;8:965. doi: 10.3389/fphar.2017.00965. eCollection 
      2017.