Bioequivalence Study of Ezetimibe Tablets Under Fed Conditions in Healthy Subjects

Pharmacokinetics Clinical Trial

Official title:

Single Oral Administration, Randomized, Open, Crossover and Bioequivalence Study of Ezetimibe Tablets Under Fasting Conditions in Healthy Subjects

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05481385
• Other study ID #: 22FWX-CZYZ-005-01
• Status: Enrolling by invitation
• Phase: Phase 1
• Start date: July 15, 2022
• Est. completion date: December 30, 2022

Study information

• Verified date: July 2022
• Source: The Affiliated Hospital of Qingdao University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The fed bioequivalence test adopts the experimental design of single center, single oral administration, random, open, two sequence, two cycle crossover and self-control.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 48
• Est. completion date: December 30, 2022
• Est. primary completion date: August 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pharmacokinetics
• Safety

Intervention

Behavioral:
• Reference preparation-Reference preparation-Test Preparation
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.
• Reference preparation-Test Preparation-Reference preparation
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.
• Test Preparation-Reference preparation-Reference preparation
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.

Locations

Country	Name	City	State
China	Phase I clinical research center	Qingdao	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
The Affiliated Hospital of Qingdao University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peak Plasma Concentration (Cmax)	Evaluation of Peak Plasma Concentration (Cmax)	96 hours
Primary	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
Primary	Area under the plasma concentration versus time curve (AUC)0-8	Evaluation of Area under the plasma concentration versus time curve (AUC)0-8	96 hours
Secondary	Incidence of abnormal blood pressure	Monitor both systolic and diastolic blood pressure	33 days
Secondary	Incidence of abnormal temperature	Monitor the temperature	33 days
Secondary	Incidence of abnormal pulse	Monitor the pulse	33 days
Secondary	Incidence of abnormal electrocardiogram waveform	Electrocardiogram inspection	33 days