Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Ezetimibe- wash out period · 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- wash out period refers to a Phase 1 bioequivalence study of ezetimibe 10 mg conducted under a wash out period design. The trial compared Acotral against Zetia in 52 healthy male volunteers aged 18 and older with hypercholesterolaemia, and it has been completed.
Ezetimibe- wash out period was studied in hypercholesterolaemia, a condition of elevated cholesterol. The single Phase 1 trial enrolled 52 healthy male volunteers in India to assess bioequivalence between Acotral and Zetia ezetimibe, using a wash out period between treatment arms. The study is completed.
GSK plc, which trades under the ticker GSK, is the developer associated with the Ezetimibe- wash out period program. The Phase 1 bioequivalence study of Acotral versus Zetia ezetimibe was conducted in India and has been completed.
Ezetimibe- wash out period is in Phase 1 development. One Phase 1 trial, NCT01597700, has been completed, and no trials are currently active. The study was randomized, active controlled, and enrolled 52 healthy male volunteers. It is an investigational program and is not approved.
Ezetimibe- wash out period has been studied in one clinical trial, NCT01597700, titled Acotral Versus Zetia Ezetimibe Bioequivalance Study. It was a completed Phase 1 trial with 52 enrolled healthy male volunteers in India, randomized and active controlled, comparing ezetimibe formulations under a wash out period design.