Bioavailability and Bioequivalence of Ezetimibe Tablets in Healthy Subjects

Study on the 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 age
• The 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 diseases
• hepatic/renal impairment
• abnormal vital signs
• drug or alcohol abuse
• smoking ≥5 cigarettes per day ,
• donation(≥300ml) o
• enrollment in other clinical trials during the 3 months prior to screening
• allergic to ezetimibe or its excipients
• any use of other prescription drugs or vitamins or caffeine/xanthine-rich beverages 48h prior to taking medication
• lactating or pregnant women