Safety of Gunghatang Tablet after Single Oral Administration in Healthy Male Volunteers, Single Center Study (궁하탕정의 단회 경구투여 후 안전성 평가를 위한 단일기관 연구)

Sung-Hu An (안성후); Hee-Ra Shin (신희라); Park Kyung-Tae (박경태); Yoon-Seung Lee (이윤승); Jonggyu Kim (김종규); Seung-ryong Yeom (염승룡); Young Dal Kwon (권영달); Hea-Young Cho (조혜영)

doi:10.18325/jkmr.2019.29.4.101

Safety of Gunghatang Tablet after Single Oral Administration in Healthy Male Volunteers, Single Center Study

Journal of Korean Medicine Rehabilitation
Abbr : JKMR
2019, 29(4), pp.101-108
DOI : 10.18325/jkmr.2019.29.4.101
Publisher : The Korean Academy Of Oriental Rehabilitation Medicine
Research Area : Medicine and Pharmacy > Korean Medicine
Received : September 15, 2019
Accepted : October 1, 2019
Published : October 31, 2019

Sung-Hu An ¹, Hee-Ra Shin ¹, Park Kyung-Tae ¹, Yoon-Seung Lee ², Jonggyu Kim ², Seung-ryong Yeom ¹, Young Dal Kwon ¹, Hea-Young Cho ³

¹원광대학교 한의과대학 광주한방병원 한방재활의학과
²원광대학교 한의과대학 전주한방병원 한방재활의학과
³차의과학대학교 약학과

Accredited

ABSTRACT

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)

KEYWORDS

Gunghatang, Herbal medicine, Drug compounding, Safety evaluation

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Journal of Korean Medicine Rehabilitation 2023 KCI Impact Factor : 0.6

Safety of Gunghatang Tablet after Single Oral Administration in Healthy Male Volunteers, Single Center Study

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Journal of Korean Medicine Rehabilitation 2023 KCI Impact Factor : 0.6

Safety of Gunghatang Tablet after Single Oral Administration in Healthy Male Volunteers, Single Center Study

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