Bioavailability and Bioequivalence of Ezetimibe Tablets in Healthy Subjects

Phase 1

Completed

• Conditions: Hyperlipidemias
• Interventions: Drug: ezetimibe tablet(Ezetrol ®); Drug: ezetimibe tablet

• Registration Number: NCT05681247
• Lead Sponsor: The Affiliated Hospital of Qingdao University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-12-17
• Primary Completion: 2018-01-29
• Study Completion: 2018-03-07
• Status Verified: 2022-12
• Study First Submitted: 2022-12-27
• Study First Submitted QC: 2022-12-27
• Last Update Submitted: 2022-12-27
• Study First Posted: 2023-01-12
• Last Update Posted: 2023-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 59

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
ezetimibe tablet(Ezetrol ®)	ezetimibe tablet(Ezetrol ®)	ezetimibe tablet reference formulation at a single dose of 10 mg
ezetimibe tablet	ezetimibe tablet	ezetimibe tablet test formulation at a single dose of 10 mg

Primary Outcome Measures

Name	Time	Method
Peak Plasma Concentration (Cmax) Peak Plasma Concentration (Cmax)	80 days	Peak Plasma Concentration (Cmax) Evaluation of Peak Plasma Concentration (Cmax)

Secondary Outcome Measures

Name	Time	Method
Area under the plasma concentration versus time curve (AUC)0-t	80 days	Evaluation of Area under the plasma concentration versus time curve (AUC)0-t

Trial Locations

Locations (1)

Clinical Research Center; 🇨🇳 Qingdao, Shandong, China