Status:
UNKNOWN
Bioequivalence of Extended Release Nifedipine Tablets in Healthy Chinese Subjects
Lead Sponsor:
Cao Yu
Conditions:
Therapeutic Equivalency
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief Summary
According to the relevant provisions of bioequivalence test, nifedipine sustained-release tablets (test preparation, t, 30mg / tablet) provided by Guangzhou bostao controlled release pharmaceutical Co...
Eligibility Criteria
Inclusion
- Healthy male or female aged 18-45.
- 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 :
June 25 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2020
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04438720
Start Date
June 25 2020
End Date
September 30 2020
Last Update
August 21 2020
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Phase I Clinical Research Center
Qingdao, Shandong, China, 266003