Bioequivalence Study of Ezetimibe Tablets Under Fed Conditions in Healthy Subjects

NCT05481385 | Unknown Phase 1

• 1 other identifier: 22FWX-CZYZ-005-01
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pharmacokinetics; Safety

Keywords

Ezetimibe

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 (4)

• Incidence of abnormal blood pressure

  33 days

• Incidence of abnormal temperature

  33 days

• Incidence of abnormal pulse

  33 days

• Incidence of abnormal electrocardiogram waveform

  33 days

Study Arms (2)

Test preparation

EXPERIMENTAL

Ezetimibe tablets: specification: 10mg; Package specification: 7 pieces / plate, 1 plate / box; Produced and provided by Changzhou Pharmaceutical Factory Co., Ltd.

Behavioral: Test Preparation-Reference preparation-Reference preparation

Reference preparation

ACTIVE COMPARATOR

Ezetimibe Tablets Ezetrol ®; Specification: 10mg, packaging specification: 10 pieces / plate, 1 plate / box; Licensee: MSD Pharma (Singapore) PTE. Ltd

Behavioral: Reference preparation-Reference preparation-Test Preparation; Behavioral: Reference preparation-Test Preparation-Reference preparation

Interventions

Reference preparation-Reference preparation-Test Preparation BEHAVIORAL

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

Reference preparation-Test Preparation-Reference preparation BEHAVIORAL

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.

Reference preparation

Test Preparation-Reference preparation-Reference preparation BEHAVIORAL

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.

Test preparation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• The Affiliated Hospital of Qingdao University: lead

Study Sites (1)

Phase I clinical research center

Qingdao, Shandong, 266003, China

Location

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: July 28, 2022
• First Posted: August 1, 2022
• Study Start: July 15, 2022
• Primary Completion: August 31, 2022
• Study Completion: December 30, 2022
• Last Updated: August 1, 2022

Record last verified: 2022-07

Locations

CN (1)