Lian-Gang Lu1, Song-Qing Wu, Dong Liang. 1. Guangdong Zhongda South China Sea Marine Biotechnology Engineering Center Co., Ltd., Guangzhou 510330, China.
Abstract
OBJECTIVE: To evaluate the tolerability for safflower peony ointment and determine its safe dosage, by selecting health volunteers and testing from the initial safety dosage, in order to provide basis for formulating administration scheme of the drug in clinical trial phase II. METHOD:Forty-six healthy volunteers were included in the open, random, dose escalation, self control clinical trial on tolerability for single dosage scheme or multi-dosage. In the single dosage scheme, dosages of test drugs were 2.16 g (four people), 4.32 g (6 people), 6.48 g (6 people), 8.62 g (6 people), 11.46 g (6 people), 15.24 g (including crude drug) for 24 hours, once everyday. In the multi-dosage scheme, dosages of test drugs were 8.62 g (6 people), 11.46 g (including crude drug) once everyday for 7 days. RESULT: The maximum safe dosage of single administration was 15.24 g (including crude drug) , while that of multiple administration 8.62 g (including crude drug). The occurrence rate of side effect was as low as 2.17%, which was recovered by medicines, without severe adverse event. CONCLUSION: The study proves the safe application of single administration and multiple administration of safflower peony ointment in human bodies, which lays a foundation for the application in the clinical trial phase II.
RCT Entities:
OBJECTIVE: To evaluate the tolerability for safflower peony ointment and determine its safe dosage, by selecting health volunteers and testing from the initial safety dosage, in order to provide basis for formulating administration scheme of the drug in clinical trial phase II. METHOD: Forty-six healthy volunteers were included in the open, random, dose escalation, self control clinical trial on tolerability for single dosage scheme or multi-dosage. In the single dosage scheme, dosages of test drugs were 2.16 g (four people), 4.32 g (6 people), 6.48 g (6 people), 8.62 g (6 people), 11.46 g (6 people), 15.24 g (including crude drug) for 24 hours, once everyday. In the multi-dosage scheme, dosages of test drugs were 8.62 g (6 people), 11.46 g (including crude drug) once everyday for 7 days. RESULT: The maximum safe dosage of single administration was 15.24 g (including crude drug) , while that of multiple administration 8.62 g (including crude drug). The occurrence rate of side effect was as low as 2.17%, which was recovered by medicines, without severe adverse event. CONCLUSION: The study proves the safe application of single administration and multiple administration of safflower peony ointment in human bodies, which lays a foundation for the application in the clinical trial phase II.