Trials / Unknown
UnknownNCT04814589
Bioequivalence of Ezetimibe Tablets in Healthy Subjects
Bioequivalence of Ezetimibe Tablets in Healthy Subjects: A Single-dose and Two-period Crossover Study
- Status
- Unknown
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 96 (estimated)
- Sponsor
- Cao Yu · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
According to the relevant provisions of bioequivalence test, ezetimibe Tablets (test preparation, T, 10mg / tablet) provided by China Resources Saike Pharmaceutical Co., Ltd. were compared with Ezetrol ® (reference preparation, R, 10mg / tablet) produced by MSD Pharma (Singapore) Pte. Ltd. to evaluate the bioequivalence of single dose in healthy subjects under fasting and fed conditions.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ezetimibe tablets | The subjects randomly received single oral administration of ezetimibe tablets 10 mg. |
| DRUG | ezetimibe tablets(Ezetrol ®) | The subjects randomly received single oral administration of ezetimibe tablets 10 mg. |
Timeline
- Start date
- 2021-03-13
- Primary completion
- 2021-06-30
- Completion
- 2021-07-31
- First posted
- 2021-03-24
- Last updated
- 2021-03-24
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT04814589. Inclusion in this directory is not an endorsement.