3.1.3. Activity: Clinical Studies

The pharmacokinetic characteristics of baicalein administered orally were evaluated in a cohort of 36 healthy Chinese subjects [93]. The study was a Phase-I single-center, randomized, double-blind, placebo-controlled, multiple ascending dose trial in which baicalein was administered at doses of 200, 400 and 600 mg once daily on days 1 and 10, 3 times daily on days 4 to 9. The absorption of the drug was rapid, with peak plasma levels evident within 2 h after administration. Treatment was found to be safe and welltolerated; adverse events were mild and spontaneously resolved. Another study, consisting of multiple phases, considered a multiple design involving a total of 110 subjects, including a randomized, double-blind, placebo-controlled, single ascending dose study with doses of baicalein ranging from 100 to 800 mg [94]. In addition to the pharmacokinetic evaluation, the effect of food on the disposition of the drug was considered. The published clinical

studies, although limited in sample dimension, indicate the favorable bioavailability and a good safety profile of baicalein, when used at suggested doses. However, to date, no studies on clinical effectiveness in the cardiovascular field are available.
