Single Oral Administration, Randomized, Open, Crossover and Bioequivalence Study of Ezetimibe Tablets Under Fasting Conditions in Healthy Subjects
Trial Snapshot
- Phase
- Phase 1
- Enrollment
- 48
- Locations
- 1
- Primary Endpoint
- Peak Plasma Concentration (Cmax)
Study Overview
Brief Summary
The fed 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 fed conditions, and to evaluate the bioequivalence of ezetimibe tablets produced by Changzhou Pharmaceutical Factory Co., Ltd. and the licensee MSD Pharma (Singapore) PTE. Ltd. To study the safety of single oral ezetimibe tablets (specification 10mg) in Chinese healthy subjects.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •• 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 Criteria
- •• Being allergy to the study medications, smoking, alcohol abuse.
- •Participation in another clinical trial within 3 months.
Outcomes
Primary Outcomes
Peak Plasma Concentration (Cmax)
Time Frame: 96 hours
Evaluation of Peak Plasma Concentration (Cmax)
Area under the plasma concentration versus time curve (AUC)0-t
Time Frame: 96 hours
Evaluation of Area under the plasma concentration versus time curve (AUC)0-t
Area under the plasma concentration versus time curve (AUC)0-∞
Time Frame: 96 hours
Evaluation of Area under the plasma concentration versus time curve (AUC)0-∞
Secondary Outcomes
- Incidence of abnormal temperature(33 days)
- Incidence of abnormal blood pressure(33 days)
- Incidence of abnormal pulse(33 days)
- Incidence of abnormal electrocardiogram waveform(33 days)