Bioavailability and Bioequivalence of Ezetimibe Tablets in Healthy Subjects

• Sponsor: The Affiliated Hospital of Qingdao University (Other)
• Overall Status: Completed
• CT.gov ID: NCT05681247
• Collaborator: (none)
• Enrollment: 59
• Location: 1
• Arms: 2
• Actual Duration (Months): 2.6
• Patients Per Site Per Month: 22.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hyperlipidemias	Drug: ezetimibe tablet; Drug: ezetimibe tablet(Ezetrol ®)	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 59 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Study on the Bioavailability and Bioequivalence of Ezetimibe Tablets in Healthy Subjects
• Actual Study Start Date: Dec 17, 2017
• Actual Primary Completion Date: Jan 29, 2018
• Actual Study Completion Date: Mar 7, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ezetimibe tablet ezetimibe tablet test formulation at a single dose of 10 mg	Drug: ezetimibe tablet; The subjects randomly received single oral administration of ezetimibe tablet 10 mg
Active Comparator: ezetimibe tablet(Ezetrol ®) ezetimibe tablet reference formulation at a single dose of 10 mg	Drug: ezetimibe tablet(Ezetrol ®); The subjects randomly received single oral administration of ezetimibe tablet (Ezetrol ®) 10 mg.

Outcome Measures

Primary Outcome Measures

1. Peak Plasma Concentration (Cmax) Peak Plasma Concentration (Cmax) [80 days]

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

Secondary Outcome Measures

1. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: 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:

• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clinical Research Center	Qingdao	Shandong	China

Sponsors and Collaborators

• The Affiliated Hospital of Qingdao University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: The Affiliated Hospital of Qingdao University
• ClinicalTrials.gov Identifier: NCT05681247
• Other Study ID Numbers: SHX-BE-201703
• First Posted: Jan 12, 2023
• Last Update Posted: Jan 12, 2023
• Last Verified: Dec 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by The Affiliated Hospital of Qingdao University: Ezetimibe Tablet, Bioequivalence, Pharmacokinetics
• Additional relevant MeSH terms: Hyperlipidemias; Ezetimibe

Study Results

No Results Posted as of Jan 12, 2023