Bioavailability and Bioequivalence of Ezetimibe Tablets in Healthy Subjects

• Status: Completed
• Trial end date: 2018-03-07
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: The Affiliated Hospital of Qingdao University
• Treatments: Ezetimibe

Criteria

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