LuoZhu , LiMei , WangYing , ShuShiqing , LiangMaozhi , MiaoJia
  • Institute of Drug Clinical Trial/GCP Center, West China Hospital, Sichuan University, Chengdu, Sichuan 610041, P. R. China;
MiaoJia, Email: miaosiyi1971@163.com
Ice Gardenia Pain Aerosol; Strychnin; Phase-Ⅰ clinical trial; Human tolerance
10.7507/1002-0179.201600468
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Objective To study the tolerance of Ice Gardenia Pain Aerosol with single and multiple dosing in healthy Chinese volunteers, evaluate the safe dosing range and the highest tolerance dose of human body, and supply proof for the dose amount in Phase-Ⅱ study. Methods Forty subjects enrolled in Ward I of a national medicine clinical experiment institute between May and September 2014 were included in this study. For single dosing experiment, 28 eligible subjects were enrolled and assigned into 5 groups to receive a single dose of 2, 6, 10, 14 and 18 puffs per time, respectively. The patient number for each group was 4, 6, 6, 6 and 6, respectively with equal number of male and female patients in each group. For the multiple dosing treatment, 12 eligible subjects were enrolled and assigned into 2 groups to receive multiple dosing of 6 and 10 puffs per time per day, respectively, for 14 days. Both the two groups had 6 male and female patients. Tolerability was evaluated by monitoring adverse events, physical examinations, laboratory tests and electrocardiogram. Results Totally, 40 subjects were enrolled and all of them completed the study. No adverse events or severe adverse events were observed or reported. No abnormal laboratory test was reported 1 hour, 2, 4, 8, 12 and 24 hours after the treatment of single dosing, and multiple dosing group had no abnormal indexes or adverse events, either. The maximum single tolerance dose was 18 puffs per time, and a single dose of 2-18 puffs per time was well tolerated; Multiple dosing of 6 and 10 puffs per day, once a day for 14 days was well tolerated. Conclusions Single and multiple dosing of Ice Gardenia Pain Aerosol are considered to be well tolerated by healthy Chinese volunteers. The maximum single tolerance dose is 18 puffs per time; multiple dosing of 6 and 10 puffs per day, once a day for 14 days is well tolerated. We suggest that the above dosing range can be chosen in the following Phase-Ⅱ study.

Citation： LuoZhu, LiMei, WangYing, ShuShiqing, LiangMaozhi, MiaoJia. Phase-Ⅰ Clinical Study on the Tolerance of Ice Gardenia Pain Aerosol in Healthy Chinese Volunteers. West China Medical Journal, 2016, 31(10): 1701-1704. doi: 10.7507/1002-0179.201600468 Copy

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