@article{ART002518043},
author={Sung-Hu An and Hee-Ra Shin and Park Kyung-Tae and Yoon-Seung Lee and Jonggyu Kim and Seung-ryong Yeom and Young Dal Kwon and Hea-Young Cho},
title={Safety of Gunghatang Tablet after Single Oral Administration in Healthy Male Volunteers, Single Center Study},
journal={Journal of Korean Medicine Rehabilitation},
issn={1229-1854},
year={2019},
volume={29},
number={4},
pages={101-108},
doi={10.18325/jkmr.2019.29.4.101}
TY - JOUR
AU - Sung-Hu An
AU - Hee-Ra Shin
AU - Park Kyung-Tae
AU - Yoon-Seung Lee
AU - Jonggyu Kim
AU - Seung-ryong Yeom
AU - Young Dal Kwon
AU - Hea-Young Cho
TI - Safety of Gunghatang Tablet after Single Oral Administration in Healthy Male Volunteers, Single Center Study
JO - Journal of Korean Medicine Rehabilitation
PY - 2019
VL - 29
IS - 4
PB - The Korean Academy Of Oriental Rehabilitation Medicine
SP - 101
EP - 108
SN - 1229-1854
AB - Objectives The purpose of this study is to evaluate the safety of Gunghatang tablet in healthy male volunteers.
Methods Single center pharmacokinetics study was carried out in healthy male volunteers. Through the laboratory test, vital sign and adverse event data, safety evaluation was conducted. Total 15 of 16 subjects who met the inclusion criteria were enrolled and three subjects were allocated to waiting group. 12 subjects were allocated by serial number according to registration order. Subjects took the maximum daily dose of the tablet on the second day of hospitalization. For the evaluation of safety, blood samples were collected and vital sign were checked 4 times (screening, before administration, after administration and follow up period) during the trial. All adverse events were recorded and summarized as frequency and percentage. All continuous data were summarized as mean and standard deviation. For comparison of variables between before administration and after administration, data were analyzed by paired T-test or Wilcoxon signed rank test (p<0.05).
Results As a result of all data related to vital sign and laboratory test in both group, there were no significant differences associated with the clinical trial drug between pre and post administration. And there was no adverse event associated with the clinical trial drug.
Conclusions Gunghatang tablet were found to be safe for healthy male volunteers. (J Korean Med Rehabil 2019;29(4):101-108)
KW - Gunghatang;Herbal medicine;Drug compounding;Safety evaluation
DO - 10.18325/jkmr.2019.29.4.101
ER -
Sung-Hu An, Hee-Ra Shin, Park Kyung-Tae, Yoon-Seung Lee, Jonggyu Kim, Seung-ryong Yeom, Young Dal Kwon and Hea-Young Cho. (2019). Safety of Gunghatang Tablet after Single Oral Administration in Healthy Male Volunteers, Single Center Study. Journal of Korean Medicine Rehabilitation, 29(4), 101-108.
Sung-Hu An, Hee-Ra Shin, Park Kyung-Tae, Yoon-Seung Lee, Jonggyu Kim, Seung-ryong Yeom, Young Dal Kwon and Hea-Young Cho. 2019, "Safety of Gunghatang Tablet after Single Oral Administration in Healthy Male Volunteers, Single Center Study", Journal of Korean Medicine Rehabilitation, vol.29, no.4 pp.101-108. Available from: doi:10.18325/jkmr.2019.29.4.101
Sung-Hu An, Hee-Ra Shin, Park Kyung-Tae, Yoon-Seung Lee, Jonggyu Kim, Seung-ryong Yeom, Young Dal Kwon, Hea-Young Cho "Safety of Gunghatang Tablet after Single Oral Administration in Healthy Male Volunteers, Single Center Study" Journal of Korean Medicine Rehabilitation 29.4 pp.101-108 (2019) : 101.
Sung-Hu An, Hee-Ra Shin, Park Kyung-Tae, Yoon-Seung Lee, Jonggyu Kim, Seung-ryong Yeom, Young Dal Kwon, Hea-Young Cho. Safety of Gunghatang Tablet after Single Oral Administration in Healthy Male Volunteers, Single Center Study. 2019; 29(4), 101-108. Available from: doi:10.18325/jkmr.2019.29.4.101
Sung-Hu An, Hee-Ra Shin, Park Kyung-Tae, Yoon-Seung Lee, Jonggyu Kim, Seung-ryong Yeom, Young Dal Kwon and Hea-Young Cho. "Safety of Gunghatang Tablet after Single Oral Administration in Healthy Male Volunteers, Single Center Study" Journal of Korean Medicine Rehabilitation 29, no.4 (2019) : 101-108.doi: 10.18325/jkmr.2019.29.4.101
Sung-Hu An; Hee-Ra Shin; Park Kyung-Tae; Yoon-Seung Lee; Jonggyu Kim; Seung-ryong Yeom; Young Dal Kwon; Hea-Young Cho. Safety of Gunghatang Tablet after Single Oral Administration in Healthy Male Volunteers, Single Center Study. Journal of Korean Medicine Rehabilitation, 29(4), 101-108. doi: 10.18325/jkmr.2019.29.4.101
Sung-Hu An; Hee-Ra Shin; Park Kyung-Tae; Yoon-Seung Lee; Jonggyu Kim; Seung-ryong Yeom; Young Dal Kwon; Hea-Young Cho. Safety of Gunghatang Tablet after Single Oral Administration in Healthy Male Volunteers, Single Center Study. Journal of Korean Medicine Rehabilitation. 2019; 29(4) 101-108. doi: 10.18325/jkmr.2019.29.4.101
Sung-Hu An, Hee-Ra Shin, Park Kyung-Tae, Yoon-Seung Lee, Jonggyu Kim, Seung-ryong Yeom, Young Dal Kwon, Hea-Young Cho. Safety of Gunghatang Tablet after Single Oral Administration in Healthy Male Volunteers, Single Center Study. 2019; 29(4), 101-108. Available from: doi:10.18325/jkmr.2019.29.4.101
Sung-Hu An, Hee-Ra Shin, Park Kyung-Tae, Yoon-Seung Lee, Jonggyu Kim, Seung-ryong Yeom, Young Dal Kwon and Hea-Young Cho. "Safety of Gunghatang Tablet after Single Oral Administration in Healthy Male Volunteers, Single Center Study" Journal of Korean Medicine Rehabilitation 29, no.4 (2019) : 101-108.doi: 10.18325/jkmr.2019.29.4.101