Bioequivalence Study of Ezetimibe Tablets Under Fasting Conditions in Healthy Subjects
Single Oral Administration, Randomized, Open, Crossover and Bioequivalence Study of Ezetimibe Tablets Under Fasting Conditions in Healthy Subjects
1 other identifier
interventional
48
0 countries
N/A
Brief Summary
The fasting bioequivalence test adopts the experimental design of single center, single oral administration, random, open, two sequence, two cycle crossover and self-control.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started May 2022
Shorter than P25 for phase_1
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 16, 2022
CompletedFirst Posted
Study publicly available on registry
May 19, 2022
CompletedStudy Start
First participant enrolled
May 26, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2022
CompletedMay 19, 2022
May 1, 2022
3 months
May 16, 2022
May 16, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Peak Plasma Concentration (Cmax)
Evaluation of Peak Plasma Concentration (Cmax)
96 hours
Area under the plasma concentration versus time curve (AUC)0-t
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-∞
Evaluation of Area under the plasma concentration versus time curve (AUC)0-∞
96 hours
Secondary Outcomes (1)
Incidence of abnormal blood pressure
33 days
Other Outcomes (3)
Incidence of abnormal temperature
33 days
Incidence of abnormal pulse
33 days
Incidence of abnormal electrocardiogram waveform
33 days
Study Arms (2)
Test preparation
EXPERIMENTALEzetimibe tablets: specification: 10mg; Package specification: 7 pieces / plate, 1 plate / box; Produced and provided by Changzhou Pharmaceutical Factory Co., Ltd.
Reference preparation
ACTIVE COMPARATOREzetimibe Tablets：Ezetrol ®， Specification: 10mg, packaging specification: 10 pieces / plate, 1 plate / box; Licensee: MSD Pharma (Singapore) PTE. Ltd.
Interventions
Under fasting conditions, subjects randomly divided into TR group were given one tablet of test preparation first, and then one tablet of reference preparation after cleaning period.
Under fasting conditions, subjects randomly divided into RT group were given one tablet of reference preparation first, and then one tablet of test preparation after cleaning period.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Being allergy to the study medications, smoking, alcohol abuse.
- Participation in another clinical trial within 3 months.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Officials
- PRINCIPAL INVESTIGATOR
Yu Cao, Doctor
National Medical Products Administration
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 16, 2022
First Posted
May 19, 2022
Study Start
May 26, 2022
Primary Completion
August 31, 2022
Study Completion
December 30, 2022
Last Updated
May 19, 2022
Record last verified: 2022-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Time Frame
- The data have been available on May 22, 2022. The duration has not been determined.
The technical achievements (including but not limited to patent right and thesis publishing right) involved in this trial, clinical research materials and achievements are owned by Zhejiang onlycom Pharmaceutical Co., Ltd. With the written consent of Zhejiang onlycom Pharmaceutical Co., Ltd., all partners have the right to publish academic papers, and the Affiliated Hospital of Qingdao University, a clinical research institution, has the right to exchange research results in academic conferences or journals.