Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01597700 | Acotral® Versus Zetia® Ezetimibe Bioequivalance Study. | PHASE1 | COMPLETED | 52 | — | — | Jan 13, 2012 | Jan 30, 2012 | Jun 20, 2017 | 1 | India |
Liquid chromatography and mass spectrometry
Safety monitoring
| Arm | Type | Description |
|---|---|---|
| Acotral® ezetimibe 10mg | EXPERIMENTAL | Subjects will be fasted overnight and receive one tablet by mouth in accordance with a randomisation list and venous blood samples will be taken at specified intervals over the ensuing 3 day. |
| Zetia® ezetimibe 10mg | ACTIVE_COMPARATOR | Subjects will be fasted overnight and receive one tablet by mouth in accordance with a randomisation list and venous blood samples will be taken at specified intervals over the ensuing 3 days. |
| Name | Type | Description |
|---|---|---|
| 10mg Ezetimibe | DRUG | 1 tablet taken by mouth |
| 10 mg Ezetimibe - wash out period | DRUG | 1 tablet taken by mouth received after wash out period |
Inclusion Criteria: * Literate healthy adult male human subjects within the age range of 18 to 45 years inclusive. * Weight not less than 50 kg. * Normal BMI \[18.5 to 24.99 kg/m2 inclusive\]. * Willingness to provide written informed consent to participate in the study and capable of giving writte...