Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Ezetimibe · 1 trial · 1 indication
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...
Ezetimibe is used for hypercholesterolaemia, a condition of high cholesterol levels in the blood. It is being developed as a small molecule therapeutic in the metabolic therapeutic area.
Ezetimibe is being developed by GSK plc, which trades under the ticker GSK. The drug is currently in Phase 1 clinical development.
Ezetimibe is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 1 trial has been completed.
Ezetimibe has one completed clinical trial, NCT01597700, titled 'Acotral® Versus Zetia® Ezetimibe Bioequivalance Study.' This Phase 1 trial enrolled 52 healthy male volunteers in India and was active-controlled.
Ezetimibe is being studied in a bioequivalence trial comparing Acotral® and Zetia®. The trial aims to assess whether these formulations of ezetimibe are bioequivalent in healthy volunteers.