Bioequivalence of Ezetimibe Tablets in Healthy Subjects

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-13

Study Completion Date

2021-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Bioequivalence Study of Ezetimibe Tablets Under Fed Conditions in Healthy Subjects

NCT05481385

Pharmacokinetics Safety

UNKNOWN PHASE1

Bioequivalence Study of Ezetimibe Tablets Under Fasting Conditions in Healthy Subjects

NCT05381870

Pharmacokinetics Safety

UNKNOWN PHASE1

Bioequivalence Study of Azilsartan Tablets in Chinese Healthy Volunteers

NCT03652792

Bioequivalence of Two Azilsartan Formulations

COMPLETED PHASE1

A Study in Healthy People to See How Zongertinib is Taken up Into the Blood When Given as Tablets Made by Two Different Manufacturers

NCT06360081

Healthy

COMPLETED PHASE1

Bioequivalence Study of Two Dabigatran Etexilate Mesylate Capsules in Healthy Subjects

NCT06876623

Bioequivalence of Dabigatran Etexilate Mesylate Capsules From Two Different Manufacturers in Healthy Chinese Subjects

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Therapeutic Equivalency

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

ezetimibe Tablets

ezetimibe tablets test formulation at a single dose of 10 mg

Group Type EXPERIMENTAL

ezetimibe tablets

Intervention Type DRUG

The subjects randomly received single oral administration of ezetimibe tablets 10 mg.

ezetimibe tablets(Ezetrol ®)

ezetimibe tablets reference formulation at a single dose of 10 mg

Group Type ACTIVE_COMPARATOR

ezetimibe tablets(Ezetrol ®)

Intervention Type DRUG

The subjects randomly received single oral administration of ezetimibe tablets 10 mg.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

ezetimibe tablets

The subjects randomly received single oral administration of ezetimibe tablets 10 mg.

Intervention Type DRUG

ezetimibe tablets(Ezetrol ®)

The subjects randomly received single oral administration of ezetimibe tablets 10 mg.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes