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CompletedNCT05681247Updated Jan 12, 2023

Bioavailability and Bioequivalence of Ezetimibe Tablets in Healthy Subjects

A Phase 1 interventional study of ezetimibe tablet and ezetimibe tablet(Ezetrol ®) in Hyperlipidemias, sponsored by The Affiliated Hospital of Qingdao University. Completed at 1 site in China. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-01-12.

Sponsored by The Affiliated Hospital of Qingdao University · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Registered 5 years after the study started (first participant enrolled Dec 2017, registered Dec 2022).
Phase
Phase 1
Study type
Interventional
Enrollment
59
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Hyperlipidemias

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Keywords

  • Ezetimibe Tablet, Bioequivalence, Pharmacokinetics
03

In context

Hyperlipidemias

821 studies on the registry are indexed under Hyperlipidemias; 105 are open to participants now.

This study's enrollment of 59 is below the median of 87 across 691 interventional studies indexed under Hyperlipidemias.

Browse Hyperlipidemias studies →

Lead sponsor

The Affiliated Hospital of Qingdao University is the lead sponsor of 142 studies on the registry; 55 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts 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

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
59 participants (actual)

Study arms

  • Experimental
    ezetimibe tablet

    ezetimibe tablet test formulation at a single dose of 10 mg

    Drug: ezetimibe tablet

  • Active comparator
    ezetimibe tablet(Ezetrol ®)

    ezetimibe tablet reference formulation at a single dose of 10 mg

    Drug: ezetimibe tablet(Ezetrol ®)

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.

06

What researchers measure

Primary outcomes

  1. Peak Plasma Concentration (Cmax) Peak Plasma Concentration (Cmax)

    Peak Plasma Concentration (Cmax) Evaluation of Peak Plasma Concentration (Cmax)

    Time frame: 80 days

Secondary outcomes

  1. Area under the plasma concentration versus time curve (AUC)0-t

    Evaluation of Area under the plasma concentration versus time curve (AUC)0-t

    Time frame: 80 days

07

Study locations

1 site
  • Clinical Research Center
    Qingdao, Shandong, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 12, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05681247
Lead sponsor
The Affiliated Hospital of Qingdao University
Responsible party
Sponsor
First posted
Jan 12, 2023
Start date
Dec 17, 2017
Primary completion
Jan 29, 2018
Completion
Mar 7, 2018
Last update
Jan 12, 2023

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.

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Discussion

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