Clinical trial NCT05381870: Bioequivalence Study of Ezetimibe Tablets Under Fasting Conditions in Healthy Subjects
Official title: Single Oral Administration, Randomized, Open, Crossover and Bioequivalence Study of Ezetimibe Tablets Under Fasting Conditions in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Pharmacokinetics
Safety
Keywords: Ezetimibe
Lead sponsor: The Affiliated Hospital of Qingdao University
Sponsor class: OTHER
Collaborators: name: Changzhou Pharmaceutical Factory Co., Ltd
First posted: 2022-05-19
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The fasting bioequivalence test adopts the experimental design of single center, single oral administration, random, open, two sequence, two cycle crossover and self-control.

Detailed description: To investigate the in vivo pharmacokinetic characteristics of ezetimibe tablets (specification 10mg) in Chinese healthy subjects after a single oral administration under fasting conditions, and to evaluate the bioequivalence of ezetimibe tablets produced by Changzhou Pharmaceutical Factory Co., Ltd. and the licensee MSD Pharma (Singapore) PTE. Ltd. To study the safety of single oral ezetimibe tablets (specification 10mg) in Chinese healthy subjects.

Eligibility criteria: Inclusion Criteria:

* Healthy male or female aged 18 and above.
* The body mass index is in the range of 18.6-28.5 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.
* The following examination show that the indicators are normal or abnormal without clinical significance. The examination including: Vital signs, physical examination, blood routine, blood biochemistry, urinalysis, pregnancy test for female, serological tests for hepatitis B virus, hepatitis C virus, human immunodeficiency virus (HIV), and syphilis virus, 12 lead ECG, breath test for alcohol, drug abuse test.
* The subjects have no family planning within 3 months and could select contraceptive method.
* Before the study, all subjects have been informed of the study's purpose, protocal, benefits, and risks, and signed the informed consent voluntarily.

Exclusion Criteria:

* Being allergy to the study medications, smoking, alcohol abuse.
* Participation in another clinical trial within 3 months.

Primary outcomes:
measure: Peak Plasma Concentration (Cmax)
timeFrame: 96 hours
measure: Area under the plasma concentration versus time curve (AUC)0-t
timeFrame: 96 hours
measure: Area under the plasma concentration versus time curve (AUC)0-∞
timeFrame: 96 hours
Secondary outcomes:
measure: Incidence of abnormal blood pressure
timeFrame: 33 days
Other outcomes:
measure: Incidence of abnormal temperature
timeFrame: 33 days
measure: Incidence of abnormal pulse
timeFrame: 33 days
measure: Incidence of abnormal electrocardiogram waveform
timeFrame: 33 days
Locations:
Study officials:
affiliation: National Medical Products Administration
name: Yu Cao, Doctor
role: PRINCIPAL_INVESTIGATOR
References: