Acotral® Versus Zetia® Ezetimibe Bioequivalance Study.
Summary
Bioequivalence study comparing test Acotral® ezetimibe 10 mg tablet manufactured by Laboratorios Phoenix, with a reference comparator Zetia® ezetimibe 10 mg tablet of Merck/Schering-Plough Pharmaceuticals. The CRO Clinigene Bangalore, will conduct the study. Fifty two healthy adult subjects who have satisfied the inclusion and exclusion criteria and given their informed consent will be entered into the study. They will be fasted and receive one tablet by mouth in accordance with a randomisation list and blood samples will be taken at specified intervals over the ensuing 3 days. Between 14 and 21 days later, subjects will receive the opposite tablet and the clinical process repeated. Subjects will be continuously monitored while in the trial clinic and at ambulatory visits with regular measurements of vital signs and questioned for adverse events. Drug concentrations will be analysed and these results compared to ascertain bioequivalence by applying statistical methods to the pharmacokinetic data; this information and all safety data will be formally reported.
Description
This is a randomized, balanced, open label, crossover, two period, two treatment, two sequence, single dose bioequivalence study comparing test Acotral® ezetimibe 10 mg tablet manufactured by Laboratorios Phoenix, Argentina with a reference comparator Zetia® ezetimibe 10 mg tablet of Merck/Schering-Plough Pharmaceuticals, USA. The CRO Clinigene International Ltd, Bangalore, India will conduct the study. Fifty two healthy male adult subjects who have satisfied the inclusion and exclusion criteria and given their written informed consent will be entered into the study. They 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; meals and water ad libitum will be allowed. Between 14 and 21 days later, subjects will return to the clinic and follow the same procedure to receive the opposite tablet and the clinical process repeated. Subjects will be continuously safety monitored while in the trial clinic and at ambulatory visits with regular measurements of vital signs and questioned for adverse events in accordance with the trial clinic SOPs. Drug concentrations will be analysed and these results compared in accordance with the study protocol to ascertain bioequivalence by applying statistical methods to the pharmacokinetic data; this information and all safety data will be formally reported to GSK.
Study Design
Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label
Conditions
Hypercholesterolaemia
Intervention
10mg Ezetimibe, 10 mg Ezetimibe - wash out period
Location
GSK Investigational Site
Electronics City, Bengalore
India
560100
Status
Completed
Source
GlaxoSmithKline
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT01597700
- Information obtained from ClinicalTrials.gov on June 14, 2012
Published on BioPortfolio: 2014-08-27T04:00:34-0400
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Medical and Biotech [MESH] Definitions
Ezetimibe, Simvastatin Drug Combination
A pharmaceutical preparation of ezetimibe and simvastatin that is used in the treatment of HYPERCHOLESTEROLEMIA and HYPERLIPIDEMIAS.
Ezetimibe
An azetidine derivative and ANTICHOLESTEREMIC AGENT that inhibits intestinal STEROL absorption. It is used to reduce total CHOLESTEROL; LDL CHOLESTEROL, and APOLIPOPROTEINS B in the treatment of HYPERLIPIDEMIAS.
Fertile Period
The period in the MENSTRUAL CYCLE that is optimal for FERTILIZATION of the OVUM and yielding PREGNANCY. The duration of fertile period depends on the life span of male GAMETES within the female reproductive tract and the time of OVULATION. It usually begins a few days before ovulation and ends on the day of ovulation.
Peripartum Period
The period shortly before, during, and immediately after giving birth.
Maximum Allowable Concentration
The maximum exposure to a biologically active physical or chemical agent that is allowed during an 8-hour period (a workday) in a population of workers, or during a 24-hour period in the general population, which does not appear to cause appreciable harm, whether immediate or delayed for any period, in the target population. (From Lewis Dictionary of Toxicology, 1st ed)
