Bioequivalence of Ezetimibe Tablets in Healthy Subjects

Therapeutic Equivalency Clinical Trial

Official title:

Bioequivalence of Ezetimibe Tablets in Healthy Subjects: A Single-dose and Two-period Crossover Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04814589
• Other study ID #: LC00-065
• Status: Recruiting
• Phase: Phase 1
• Start date: March 13, 2021
• Est. completion date: July 31, 2021

Study information

• Verified date: March 2021
• Source: The Affiliated Hospital of Qingdao University
• Contact: yu Cao, doctor
• Phone: 86 18661809090
• Email: caoyu1767[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

According to the relevant provisions of bioequivalence test, ezetimibe Tablets (test preparation, T, 10mg / tablet) provided by China Resources Saike Pharmaceutical Co., Ltd. were compared with Ezetrol ® (reference preparation, R, 10mg / tablet) produced by MSD Pharma (Singapore) Pte. Ltd. to evaluate the bioequivalence of single dose in healthy subjects under fasting and fed conditions.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 96
• Est. completion date: July 31, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Healthy male or female subjects =18 years of age, with appropriate sex ratio;

• The body mass index is in the range of 19.0-26.0 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.

• 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 and Nicotine 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:

• Alanine aminotransferase >1.0×ULN ,Aspartate aminotransferase >1.0×ULN or Total bilirubin >1.0×ULN.

• Subjects with allergic constitution.

• Being allergy to the study medications, smoking, alcohol abuse.

• Participation in another clinical trial within 3 months.

Related Conditions & MeSH terms

• Therapeutic Equivalency

Intervention

Drug:
• ezetimibe tablets
The subjects randomly received single oral administration of ezetimibe tablets 10 mg.
• ezetimibe tablets(Ezetrol ®)
The subjects randomly received single oral administration of ezetimibe tablets 10 mg.

Locations

Country	Name	City	State
China	Phase ? Clinical Research Center	Qingdao	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Cao Yu

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)	90 days
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	90 days
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	90 days
Secondary	Incidence of Treatment-Emergent Adverse Events	Collection of adverse events	90 days
Secondary	Incidence of abnormal blood pressure	Monitor both systolic and diastolic blood pressure	90 days
Secondary	Incidence of abnormal temperature	Monitor the temperature	90 days