Status:
COMPLETED
Bioequivalence of Levamlodipine Besylate Tablets in Healthy Chinese Subjects
Lead Sponsor:
The Affiliated Hospital of Qingdao University
Conditions:
Healthy Subjects
Eligibility:
All Genders
19-48 years
Phase:
PHASE1
Brief Summary
The single-dose randomized, open-label, two-period crossover study was executed in the Phase I Clinical Research Center of the Affiliated Hospital of Qingdao University. According to the random table ...
Eligibility Criteria
Inclusion
- 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
- Being allergy to the study medications, smoking, alcohol abuse.
- Participation in another clinical trial within 3 months.
Key Trial Info
Start Date :
November 13 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 15 2019
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT04411875
Start Date
November 13 2018
End Date
February 15 2019
Last Update
June 5 2020
Active Locations (1)
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1
Phase Ⅰ Clinical Research Center
Qingdao, Shandong, China, 266003