Bioavailability and Bioequivalence of Ezetimibe Tablets in Healthy Subjects

Study on the Bioavailability and Bioequivalence of Ezetimibe Tablets in Healthy Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05681247

Enrollment

Registered

2023-01-12

Start date

2017-12-17

Completion date

2018-03-07

Last updated

2023-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hyperlipidemias

Keywords

Ezetimibe Tablet, Bioequivalence, Pharmacokinetics

Brief summary

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.

Interventions

DRUGezetimibe tablet

The subjects randomly received single oral administration of ezetimibe tablet 10 mg

DRUGezetimibe tablet(Ezetrol ®)

The subjects randomly received single oral administration of ezetimibe tablet (Ezetrol ®) 10 mg.

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Peak Plasma Concentration (Cmax) Peak Plasma Concentration (Cmax)	80 days	Peak Plasma Concentration (Cmax) Evaluation of Peak Plasma Concentration (Cmax)

Secondary

Measure	Time frame	Description
Area under the plasma concentration versus time curve (AUC)0-t	80 days	Evaluation of Area under the plasma concentration versus time curve (AUC)0-t

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026