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Ezetimibe- wash out period

Phase 1

Hypercholesterolaemia | Small molecule | Metabolic |GSK plc|Last Updated: Jun 20, 2017

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment52

FDA Designations

No designations recorded

Clinical trial landscape

Ezetimibe- wash out period · 1 trial · 1 indication

Phase 1 1
NCT01597700Acotral® Versus Zetia® Ezetimibe Bioequivalance Study.Hypercholesterolaemia
COMPLETED52 Analytics
PHASE1COMPLETED
Acotral® Versus Zetia® Ezetimibe Bioequivalance Study.
Hypercholesterolaemia
NCT0159770052
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Study Endpoints

Primary Endpoints

Changes from baseline in plasma ezetimibe concentrations in time after dosing
At 0 time and up to 72 hours after last dose

Liquid chromatography and mass spectrometry

Number of participants with adverse events
At 0 time and up to 72 hours after last dose

Safety monitoring

Number of participants with changes in haematology and/or chemistry
21 to 0 days before first dose and 3 days after last dose
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeOTHER

Treatment Arms

ArmTypeDescription
Acotral® ezetimibe 10mgEXPERIMENTALSubjects 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 10mgACTIVE_COMPARATORSubjects 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.

Interventions

NameTypeDescription
10mg EzetimibeDRUG1 tablet taken by mouth
10 mg Ezetimibe - wash out periodDRUG1 tablet taken by mouth received after wash out period
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Eligibility Criteria

Age Range18 Years to 45 Years
SexMALE
Healthy VolunteersYes
Study Sites1

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...

Countries:India
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