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

궁하탕정의 단회 경구투여 후 안전성 평가를 위한 단일기관 연구

  • An, Sung-Hu (Department of Korean Rehabilitation Medicine, Gwangju Medical Center, College of Korean Medicine, Wonkwang University) ;
  • Shin, Hee-Ra (Department of Korean Rehabilitation Medicine, Gwangju Medical Center, College of Korean Medicine, Wonkwang University) ;
  • Park, Kyungtae (Department of Korean Rehabilitation Medicine, Gwangju Medical Center, College of Korean Medicine, Wonkwang University) ;
  • Lee, Yoon-Seung (Department of Korean Rehabilitation Medicine, Jeonju Medical Center, Wonkwang University) ;
  • Kim, Jonggyu (Department of Korean Rehabilitation Medicine, Jeonju Medical Center, Wonkwang University) ;
  • Yeom, Seung-Ryong (Department of Korean Rehabilitation Medicine, Gwangju Medical Center, College of Korean Medicine, Wonkwang University) ;
  • Kwon, Young-Dal (Department of Korean Rehabilitation Medicine, Gwangju Medical Center, College of Korean Medicine, Wonkwang University) ;
  • Cho, Hea-Young (College of Pharmacy, CHA University)
  • 안성후 (원광대학교 한의과대학 광주한방병원 한방재활의학과) ;
  • 신희라 (원광대학교 한의과대학 광주한방병원 한방재활의학과) ;
  • 박경태 (원광대학교 한의과대학 광주한방병원 한방재활의학과) ;
  • 이윤승 (원광대학교 한의과대학 전주한방병원 한방재활의학과) ;
  • 김종규 (원광대학교 한의과대학 전주한방병원 한방재활의학과) ;
  • 염승룡 (원광대학교 한의과대학 광주한방병원 한방재활의학과) ;
  • 권영달 (원광대학교 한의과대학 광주한방병원 한방재활의학과) ;
  • 조혜영 (차의과학대학교 약학과)
  • Received : 2019.09.15
  • Accepted : 2019.10.01
  • Published : 2019.10.31

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.

Acknowledgement

Supported by : 전라남도

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