- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05481385
Bioequivalence Study of Ezetimibe Tablets Under Fed Conditions in Healthy Subjects
July 28, 2022 updated by: The Affiliated Hospital of Qingdao University
Single Oral Administration, Randomized, Open, Crossover and Bioequivalence Study of Ezetimibe Tablets Under Fasting Conditions in Healthy Subjects
The fed bioequivalence test adopts the experimental design of single center, single oral administration, random, open, two sequence, two cycle crossover and self-control.
Study Overview
Status
Enrolling by invitation
Conditions
Detailed Description
To investigate the in vivo pharmacokinetic characteristics of ezetimibe tablets (specification 10mg) in Chinese healthy subjects after a single oral administration under fed conditions, and to evaluate the bioequivalence of ezetimibe tablets produced by Changzhou Pharmaceutical Factory Co., Ltd. and the licensee MSD Pharma (Singapore) PTE. Ltd.
To study the safety of single oral ezetimibe tablets (specification 10mg) in Chinese healthy subjects.
Study Type
Interventional
Enrollment (Anticipated)
48
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Shandong
-
Qingdao, Shandong, China, 266003
- Phase I Clinical Research Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
• Healthy male or female aged 18 and above.
- The body mass index is in the range of 18.6-28.5 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.
- The following examination show that the indicators are normal or abnormal without clinical significance. The examination including: Vital signs, physical examination, blood routine, blood biochemistry, urinalysis, pregnancy test for female, serological tests for hepatitis B virus, hepatitis C virus, human immunodeficiency virus (HIV), and syphilis virus, 12 lead ECG, breath test for alcohol, drug abuse test.
- The subjects have no family planning within 3 months and could select contraceptive method.
- Before the study, all subjects have been informed of the study's purpose, protocal, benefits, and risks, and signed the informed consent voluntarily.
Exclusion Criteria:
• Being allergy to the study medications, smoking, alcohol abuse.
- Participation in another clinical trial within 3 months.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Test preparation
Ezetimibe tablets: specification: 10mg; Package specification: 7 pieces / plate, 1 plate / box; Produced and provided by Changzhou Pharmaceutical Factory Co., Ltd.
|
Under fed conditions, subjects randomly divided into RTR group were given one tablet of test preparation first, and then one tablet of reference preparation after cleaning period, and then one tablet of reference preparation after cleaning period.
|
Active Comparator: Reference preparation
Ezetimibe Tablets Ezetrol ®; Specification: 10mg, packaging specification: 10 pieces / plate, 1 plate / box; Licensee: MSD Pharma (Singapore) PTE.
Ltd
|
Under fed conditions, subjects randomly divided into RRT group were given one tablet of reference preparation first, and then one tablet of reference preparation after cleaning period, and then one tablet of test preparation after cleaning period.
Under fed conditions, subjects randomly divided into RTR group were given one tablet of reference preparation first, and then one tablet of test preparation after cleaning period, and then one tablet of reference preparation after cleaning period.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Peak Plasma Concentration (Cmax)
Time Frame: 96 hours
|
Evaluation of Peak Plasma Concentration (Cmax)
|
96 hours
|
Area under the plasma concentration versus time curve (AUC)0-t
Time Frame: 96 hours
|
Evaluation of Area under the plasma concentration versus time curve (AUC)0-t
|
96 hours
|
Area under the plasma concentration versus time curve (AUC)0-∞
Time Frame: 96 hours
|
Evaluation of Area under the plasma concentration versus time curve (AUC)0-∞
|
96 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of abnormal blood pressure
Time Frame: 33 days
|
Monitor both systolic and diastolic blood pressure
|
33 days
|
Incidence of abnormal temperature
Time Frame: 33 days
|
Monitor the temperature
|
33 days
|
Incidence of abnormal pulse
Time Frame: 33 days
|
Monitor the pulse
|
33 days
|
Incidence of abnormal electrocardiogram waveform
Time Frame: 33 days
|
Electrocardiogram inspection
|
33 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 15, 2022
Primary Completion (Anticipated)
August 31, 2022
Study Completion (Anticipated)
December 30, 2022
Study Registration Dates
First Submitted
July 28, 2022
First Submitted That Met QC Criteria
July 28, 2022
First Posted (Actual)
August 1, 2022
Study Record Updates
Last Update Posted (Actual)
August 1, 2022
Last Update Submitted That Met QC Criteria
July 28, 2022
Last Verified
July 1, 2022
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 22FWX-CZYZ-005-01
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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