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Bioavailability and Bioequivalence of Ezetimibe Tablets in Healthy Subjects

Primary Purpose

Hyperlipidemias

Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
ezetimibe tablet
ezetimibe tablet(Ezetrol ®)
Sponsored by
The Affiliated Hospital of Qingdao University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hyperlipidemias focused on measuring Ezetimibe Tablet, Bioequivalence, Pharmacokinetics

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Clinical Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

ezetimibe tablet

ezetimibe tablet(Ezetrol ®)

Arm Description

ezetimibe tablet test formulation at a single dose of 10 mg

ezetimibe tablet reference formulation at a single dose of 10 mg

Outcomes

Primary Outcome Measures

Peak Plasma Concentration (Cmax) Peak Plasma Concentration (Cmax)
Peak Plasma Concentration (Cmax) Evaluation of Peak Plasma Concentration (Cmax)

Secondary Outcome Measures

Area under the plasma concentration versus time curve (AUC)0-t
Evaluation of Area under the plasma concentration versus time curve (AUC)0-t

Full Information

First Posted
December 27, 2022
Last Updated
December 27, 2022
Sponsor
The Affiliated Hospital of Qingdao University
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1. Study Identification

Unique Protocol Identification Number
NCT05681247
Brief Title
Bioavailability and Bioequivalence of Ezetimibe Tablets in Healthy Subjects
Official Title
Study on the Bioavailability and Bioequivalence of Ezetimibe Tablets in Healthy Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
December 17, 2017 (Actual)
Primary Completion Date
January 29, 2018 (Actual)
Study Completion Date
March 7, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Affiliated Hospital of Qingdao University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperlipidemias
Keywords
Ezetimibe Tablet, Bioequivalence, Pharmacokinetics

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
59 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ezetimibe tablet
Arm Type
Experimental
Arm Description
ezetimibe tablet test formulation at a single dose of 10 mg
Arm Title
ezetimibe tablet(Ezetrol ®)
Arm Type
Active Comparator
Arm Description
ezetimibe tablet reference formulation at a single dose of 10 mg
Intervention Type
Drug
Intervention Name(s)
ezetimibe tablet
Intervention Description
The subjects randomly received single oral administration of ezetimibe tablet 10 mg
Intervention Type
Drug
Intervention Name(s)
ezetimibe tablet(Ezetrol ®)
Intervention Description
The subjects randomly received single oral administration of ezetimibe tablet (Ezetrol ®) 10 mg.
Primary Outcome Measure Information:
Title
Peak Plasma Concentration (Cmax) Peak Plasma Concentration (Cmax)
Description
Peak Plasma Concentration (Cmax) Evaluation of Peak Plasma Concentration (Cmax)
Time Frame
80 days
Secondary Outcome Measure Information:
Title
Area under the plasma concentration versus time curve (AUC)0-t
Description
Evaluation of Area under the plasma concentration versus time curve (AUC)0-t
Time Frame
80 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
Clinical Research Center
City
Qingdao
State/Province
Shandong
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Bioavailability and Bioequivalence of Ezetimibe Tablets in Healthy Subjects

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