Bioequivalence of Ezetimibe Tablets in Healthy Subjects

Cao Yu

Status and phase: Unknown; Phase 1

Conditions: Therapeutic Equivalency

Treatments: Drug: ezetimibe tablets; Drug: ezetimibe tablets(Ezetrol ®)

Study type: Interventional

Funder types: Other

Identifiers

NCT04814589

LC00-065

Details and patient eligibility

About

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.

Enrollment: 96 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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96 participants in 2 patient groups

ezetimibe Tablets

Experimental group

Description:

ezetimibe tablets test formulation at a single dose of 10 mg

Treatment:

Drug: ezetimibe tablets

ezetimibe tablets(Ezetrol ®)

Active Comparator group

Description:

ezetimibe tablets reference formulation at a single dose of 10 mg

Treatment:

Drug: ezetimibe tablets(Ezetrol ®)