Status:
UNKNOWN
Bioequivalence of Ezetimibe Tablets in Healthy Subjects
Lead Sponsor:
Cao Yu
Conditions:
Therapeutic Equivalency
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 Ezetro...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 13 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2021
Estimated Enrollment :
96 Patients enrolled
Trial Details
Trial ID
NCT04814589
Start Date
March 13 2021
End Date
July 31 2021
Last Update
March 24 2021
Active Locations (1)
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1
Phase Ⅰ Clinical Research Center
Qingdao, Shandong, China, 266003