Bioavailability and Bioequivalence of Ezetimibe Tablets in Healthy Subjects

Qingdao University

Status and phase: Completed; Phase 1

Conditions: Hyperlipidemias

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

Study type: Interventional

Funder types: Other

Identifiers

NCT05681247

SHX-BE-201703

Details and patient eligibility

About

This study was conducted to assess the bioequivalence of the ezetimibe tablet to Ezetrol ® in healthy Chinese volunteers and estimate the pharmacokinetic profiles of ezetimibe tablet.

Enrollment: 59 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy male or female subjects ≥18 years of age
• The body mass index is in the range of 18.0-26.0 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.
• Serum total cholesterol was between 2.9 and 5.0mmol/L (not including critical value).

Exclusion criteria

• any medical history of cardiovascular, digestive, respiratory, nervous or ematological diseases
• hepatic/renal impairment
• abnormal vital signs
• drug or alcohol abuse
• smoking ≥5 cigarettes per day ,
• donation(≥300ml) o
• enrollment in other clinical trials during the 3 months prior to screening
• allergic to ezetimibe or its excipients
• any use of other prescription drugs or vitamins or caffeine/xanthine-rich beverages 48h prior to taking medication
• lactating or pregnant women

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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59 participants in 2 patient groups

ezetimibe tablet

Experimental group

Description:

ezetimibe tablet test formulation at a single dose of 10 mg

Treatment:

Drug: ezetimibe tablet

ezetimibe tablet(Ezetrol ®)

Active Comparator group

Description:

ezetimibe tablet reference formulation at a single dose of 10 mg

Treatment:

Drug: ezetimibe tablet(Ezetrol ®)