Pharmacokinetics, Safety
Conditions
Keywords
Ezetimibe
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 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.
Interventions
BEHAVIORALTest Preparation-Reference preparation
Under fasting conditions, subjects randomly divided into TR group were given one tablet of test preparation first, and then one tablet of reference preparation after cleaning period.
BEHAVIORALReference preparation-Test Preparation
Under fasting conditions, subjects randomly divided into RT group were given one tablet of reference preparation first, and then one tablet of test preparation after cleaning period.
Sponsors
Changzhou Pharmaceutical Factory Co., Ltd
The Affiliated Hospital of Qingdao University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Peak Plasma Concentration (Cmax) | 96 hours | Evaluation of Peak Plasma Concentration (Cmax) |
| Area under the plasma concentration versus time curve (AUC)0-∞ | 96 hours | Evaluation of Area under the plasma concentration versus time curve (AUC)0-∞ |
| Area under the plasma concentration versus time curve (AUC)0-t | 96 hours | Evaluation of Area under the plasma concentration versus time curve (AUC)0-t |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of abnormal blood pressure | 33 days | Monitor both systolic and diastolic blood pressure |
Other
| Measure | Time frame | Description |
|---|---|---|
| Incidence of abnormal temperature | 33 days | Monitor the temperature |
| Incidence of abnormal electrocardiogram waveform | 33 days | Electrocardiogram inspection |
| Incidence of abnormal pulse | 33 days | Monitor the pulse |
Contacts
Primary ContactXin Li, Doctor
Backup ContactYu Cao, Doctor
Outcome results
None listed