Bioequivalence of Ezetimibe Tablets in Healthy Subjects
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: ezetimibe Tablets ezetimibe tablets test formulation at a single dose of 10 mg |
Drug: ezetimibe tablets
The subjects randomly received single oral administration of ezetimibe tablets 10 mg.
|
| Active Comparator: ezetimibe tablets(Ezetrol ®) ezetimibe tablets reference formulation at a single dose of 10 mg |
Drug: ezetimibe tablets(Ezetrol ®)
The subjects randomly received single oral administration of ezetimibe tablets 10 mg.
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
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Healthy male or female subjects ≥18 years of age, with appropriate sex ratio;
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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.
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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.
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The subjects have no family planning within 3 months and could select contraceptive method.
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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:
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Alanine aminotransferase >1.0×ULN ,Aspartate aminotransferase >1.0×ULN or Total bilirubin >1.0×ULN.
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Subjects with allergic constitution.
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Being allergy to the study medications, smoking, alcohol abuse.
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Participation in another clinical trial within 3 months.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Phase Ⅰ Clinical Research Center | Qingdao | Shandong | China | 266003 |
Sponsors and Collaborators
- Cao Yu
Investigators
- Principal Investigator: yu Cao, doctor, the study director of phase I clinical research center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- LC00-065