Chronic Low Back Pain Clinical Trial
Official title:
A Phase 1, Placebo-controlled, Randomized, Parallel Group Study to Evaluate the Tolerability, Safety and Pharmacokinetics of a Topical Patch AB001 Following Single and Repeated Administration in Healthy Subjects
The study evaluates the safety, tolerability and pharmacokinetics of single and repeated doses of topical AB001 patch and the bioavailability relative to the oral capsule and topical positive comparative patch.
Eligible subjects will be randomly assigned to Treatment goup A, B and C.
In the experiment group A, 12 subjects with a ratio of 10:2 will receive one patch of AB001
or placebo batch on Day 1 of period 1, respectively, after a wash-out period of 14 days, 10
subjects received AB001 patch will be administered with an oral capsule of active ingredient
on Day 20 of period 2.
In the experiment group B, 12 subjects with a ratio of 10:2 will receive two patches of AB001
or two placebo batches on Day 1 respectively, and then two patches daily from Day 8 to Day
20.
In the active comparator group C, 10 subjects will receive one patch of positive comparative
patch on Day 1, and then once patch every two days from Day 8 to Day 20.
The tolerability, safety and pharmacokinetics of topical AB001 patch will be assessed in this
study.
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