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KMID : 0895820190290040101
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Journal of Oriental Rehabilitation Medicine
2019 Volume.29 No. 4 p.101 ~ p.108
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Safety of Gunghatang Tablet after Single Oral Administration in Healthy Male Volunteers, Single Center Study
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An Sung-Hu
Shin Hee-Ra
Park Kyung-Tae
Lee Yoon-Seung
Kim Jong-Gyu
Yeom Seung-Ryong
Kwon Young-Dal
Cho Hea-Young
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Abstract
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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.
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KEYWORD
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Gunghatang, Herbal medicine, Drug compounding, Safety evaluation
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