Status:
UNKNOWN
Bioequivalence Study of Ezetimibe Tablets Under Fasting Conditions in Healthy Subjects
Lead Sponsor:
The Affiliated Hospital of Qingdao University
Collaborating Sponsors:
Changzhou Pharmaceutical Factory Co., Ltd
Conditions:
Pharmacokinetics
Safety
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The fasting bioequivalence test adopts the experimental design of single center, single oral administration, random, open, two sequence, two cycle crossover and self-control.
Detailed Description
To investigate the in vivo pharmacokinetic characteristics of ezetimibe tablets (specification 10mg) in Chinese healthy subjects after a single oral administration under fasting conditions, and to eva...
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 :
May 26 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2022
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT05381870
Start Date
May 26 2022
End Date
December 30 2022
Last Update
May 19 2022
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.