Bioavailability and Bioequivalence of Ezetimibe Tablets in Healthy Subjects

This study was conducted to assess the bioequivalence of the ezetimibe tablet to Ezetrol ® in healthy Chinese volunteers and estimate the pharmacokinetic profiles of ezetimibe tablet.

Inclusion Criteria:Healthy male or female subjects ≥18 years of ageThe body mass index is in the range of 18.0-26.0 kg/m2 (including the critical value).The weight of male is not less than 50.0 kg, and that of female is not less than 45.0 kg.Serum total cholesterol was between 2.9 and 5.0mmol/L (not including critical value).Exclusion Criteria:any medical history of cardiovascular, digestive, respiratory, nervous or ematological diseaseshepatic/renal impairmentabnormal vital signsdrug or alcohol abusesmoking ≥5 cigarettes per day ,donation(≥300ml) oenrollment in other clinical trials during the 3 months prior to screeningallergic to ezetimibe or its excipientsany use of other prescription drugs or vitamins or caffeine/xanthine-rich beverages 48h prior to taking medicationlactating or pregnant women