Bioavailability and Bioequivalence of Ezetimibe Tablets in Healthy Subjects
NCT ID: NCT05681247
Last Updated: 2023-01-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
59 participants
INTERVENTIONAL
2017-12-17
2018-03-07
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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ezetimibe tablet
ezetimibe tablet test formulation at a single dose of 10 mg
ezetimibe tablet
The subjects randomly received single oral administration of ezetimibe tablet 10 mg
ezetimibe tablet(Ezetrol ®)
ezetimibe tablet reference formulation at a single dose of 10 mg
ezetimibe tablet(Ezetrol ®)
The subjects randomly received single oral administration of ezetimibe tablet (Ezetrol ®) 10 mg.
Interventions
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ezetimibe tablet
The subjects randomly received single oral administration of ezetimibe tablet 10 mg
ezetimibe tablet(Ezetrol ®)
The subjects randomly received single oral administration of ezetimibe tablet (Ezetrol ®) 10 mg.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
Yes
Sponsors
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The Affiliated Hospital of Qingdao University
OTHER
Responsible Party
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Locations
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Clinical Research Center
Qingdao, Shandong, China
Countries
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References
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Sun F, Liu Y, Li T, Lin P, Jiang X, Li X, Wang C, Gao X, Ma Y, Fu Y, Cao Y. Pharmacokinetics and bioequivalence of Ezetimibe tablet versus Ezetrol(R):an open-label, randomized, two-sequence crossover study in healthy Chinese subjects. BMC Pharmacol Toxicol. 2023 Feb 3;24(1):7. doi: 10.1186/s40360-023-00649-y.
Other Identifiers
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SHX-BE-201703
Identifier Type: -
Identifier Source: org_study_id
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