A Phase 2, Multicenter, Double-blind and Placebo and Active Control Study to Evaluate the Initial Efficacy and Safety of X0002 Spray in Treatment of Subjects With Osteoarthritis of the Knee
This study is a randomized, double-blind clinical trial in a Chinese population.
比较盐酸布洛胺喷雾剂与布洛芬乳膏剂单次外用给药在健康受试者中的药代动力学特征的Ⅰ期研究
[Translation] Phase I study comparing the pharmacokinetic characteristics of a single topical administration of ibuprofen hydrochloride spray and ibuprofen cream in healthy subjects
本试验主要目的是比较盐酸布洛胺喷雾剂和5%布洛芬乳膏单次外用后的药代动力学特征。次要目的是比较盐酸布洛胺喷雾剂和5%布洛芬乳膏单次外用后的安全性和耐受性。
[Translation] The primary objective of this trial was to compare the pharmacokinetic characteristics of ibuprofen hydrochloride spray and 5% ibuprofen cream after a single topical application. The secondary objective was to compare the safety and tolerability of ibuprofen hydrochloride spray and 5% ibuprofen cream after a single topical application.
Study of X0002 Following Escalating Single and Multiple Doses Administered as Topical Application in Healthy Volunteers
Primary Objectives:
To evaluate the safety and tolerability of escalating single and multiple doses of X0002 administered as a topical application.
Secondary Objectives:
To characterize the single and and multiple pharmacokinetics of escalating doses of X0002 and its active metabolite ibuprofen as a topical application.
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