Bioavailability and Bioequivalence of Ezetimibe Tablets in Healthy Subjects
Study on the Bioavailability and Bioequivalence of Ezetimibe Tablets in Healthy Subjects
1 other identifier
interventional
59
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Dec 2017
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 17, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 29, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
March 7, 2018
CompletedFirst Submitted
Initial submission to the registry
December 27, 2022
CompletedFirst Posted
Study publicly available on registry
January 12, 2023
CompletedJanuary 12, 2023
December 1, 2022
1 month
December 27, 2022
December 27, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Peak Plasma Concentration (Cmax) Peak Plasma Concentration (Cmax)
Peak Plasma Concentration (Cmax) Evaluation of Peak Plasma Concentration (Cmax)
80 days
Secondary Outcomes (1)
Area under the plasma concentration versus time curve (AUC)0-t
80 days
Study Arms (2)
ezetimibe tablet
EXPERIMENTALezetimibe tablet test formulation at a single dose of 10 mg
ezetimibe tablet(Ezetrol ®)
ACTIVE COMPARATORezetimibe tablet reference formulation at a single dose of 10 mg
Interventions
The subjects randomly received single oral administration of ezetimibe tablet 10 mg
The subjects randomly received single oral administration of ezetimibe tablet (Ezetrol ®) 10 mg.
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Clinical Research Center
Qingdao, Shandong, China
Related Publications (1)
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.
PMID: 36737825DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 27, 2022
First Posted
January 12, 2023
Study Start
December 17, 2017
Primary Completion
January 29, 2018
Study Completion
March 7, 2018
Last Updated
January 12, 2023
Record last verified: 2022-12
Data Sharing
- IPD Sharing
- Will not share