Therapeutic Equivalency
Conditions
Brief summary
According to the relevant provisions of bioequivalence test, ezetimibe Tablets (test preparation, T, 10mg / tablet) provided by China Resources Saike Pharmaceutical Co., Ltd. were compared with Ezetrol ® (reference preparation, R, 10mg / tablet) produced by MSD Pharma (Singapore) Pte. Ltd. to evaluate the bioequivalence of single dose in healthy subjects under fasting and fed conditions.
Interventions
The subjects randomly received single oral administration of ezetimibe tablets 10 mg.
DRUGezetimibe tablets(Ezetrol ®)
The subjects randomly received single oral administration of ezetimibe tablets 10 mg.
Sponsors
Cao Yu
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Healthy male or female subjects ≥18 years of age, with appropriate sex ratio; * The body mass index is in the range of 19.0-26.0 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. * 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 and Nicotine 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
* Alanine aminotransferase \>1.0×ULN ,Aspartate aminotransferase \>1.0×ULN or Total bilirubin \>1.0×ULN. * Subjects with allergic constitution. * Being allergy to the study medications, smoking, alcohol abuse. * Participation in another clinical trial within 3 months.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Peak Plasma Concentration (Cmax) | 90 days | Evaluation of Peak Plasma Concentration (Cmax) |
| Area under the plasma concentration versus time curve (AUC)0-t | 90 days | Evaluation of Area under the plasma concentration versus time curve (AUC)0-t |
| Area under the plasma concentration versus time curve (AUC)0-∞ | 90 days | Evaluation of Area under the plasma concentration versus time curve (AUC)0-∞ |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events | 90 days | Collection of adverse events |
| Incidence of abnormal blood pressure | 90 days | Monitor both systolic and diastolic blood pressure |
| Incidence of abnormal temperature | 90 days | Monitor the temperature |
Countries
China
Contacts
Primary Contactyu Cao, doctor
Outcome results
None listed