Bioequivalence Study Of Atorvastatin Tablets In Human Volunteers
By: Asif Ali Bokhari
| Dr. Sualeha Riffat.
Contributor(s): Prpf. Dr. Muhammad Ashraf.
Material type: 
BookPublisher: 2012Subject(s): Department of Pharmaoclogy & ToxicologyDDC classification: 1480,T Dissertation note: Main purpose of this clinical trail was to evaluate bioequivalence parameters of two generic drug products. It was a randomized, single dose, two-period crossover trial. Study was done on 12 volunteers with the age limit of 18-45yrs. Inclusion and exclusion criteria was used for volunteers selection and the study conducted with two week washout period. Each volunteer received one tablet of atorvastatin (reference or test) 10mg. Almost 13 blood samples of 5ml were collected at predefined time intervals. Blood samples were collected in heparinized vacuette. Blood was centrifuged after sampling and stored at -80°C till analysis. Serum atorvastatin levels were examined by using high performance liquid chromatography (HPLC) method mobile phase was a mixture of Sodium di-hydrogen phosphate buffer and acetonitrile 65:35 v/v pumped at flow rate of 1ml/min at a wavelength of 260nm. Two compartmental analysis was used for evaluating bioequivalence parameters to evaluate the both drugs were bioequivalent or not .2 major parameters of bioequivalencepeak plasma concentration Cmax and area under the curve AUC 0-t were evaluated. By statistical analysis, 90% confidence interval for area under the curve AUC 0-t was found to be 0.5972 - 1.7093, it was not within the range (0.80 - 1.25) proving an in equivalence between the two products so it shows that area under the curve AUC 0-t for both drugs is not equivalent. By statistical analysis, 90% confidence interval for peak plasma concentration Cmax found to be 0.3840 - 3.6638., it was not within the range (0.80 - 1.25). So it is evident that peak plasma concentration Cmax for both drugs is not equivalent. So, it was concluded that both of the drugs were not bioequivalent. From the given data, it is concluded that both the drugs produced uncomparable results. So it can be concluded that Lipiget cannot be used in replacement of Lipitor.
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Thesis
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UVAS Library Thesis Section | Veterinary Science | 1480,T (Browse shelf) | Available | 1480,T |
Main purpose of this clinical trail was to evaluate bioequivalence parameters of two generic drug products. It was a randomized, single dose, two-period crossover trial. Study was done on 12 volunteers with the age limit of 18-45yrs. Inclusion and exclusion criteria was used for volunteers selection and the study conducted with two week washout period. Each volunteer received one tablet of atorvastatin (reference or test) 10mg. Almost 13 blood samples of 5ml were collected at predefined time intervals. Blood samples were collected in heparinized vacuette. Blood was centrifuged after sampling and stored at -80°C till analysis. Serum atorvastatin levels were examined by using high performance liquid chromatography (HPLC) method mobile phase was a mixture of Sodium di-hydrogen phosphate buffer and acetonitrile 65:35 v/v pumped at flow rate of 1ml/min at a wavelength of 260nm. Two compartmental analysis was used for evaluating bioequivalence parameters to evaluate the both drugs were bioequivalent or not .2 major parameters of bioequivalencepeak plasma concentration Cmax and area under the curve AUC 0-t were evaluated. By statistical analysis, 90% confidence interval for area under the curve AUC 0-t was found to be 0.5972 - 1.7093, it was not within the range (0.80 - 1.25) proving an in equivalence between the two products so it shows that area under the curve AUC 0-t for both drugs is not equivalent. By statistical analysis, 90% confidence interval for peak plasma concentration Cmax found to be 0.3840 - 3.6638., it was not within the range (0.80 - 1.25). So it is evident that peak plasma concentration Cmax for both drugs is not equivalent. So, it was concluded that both of the drugs were not bioequivalent. From the given data, it is concluded that both the drugs produced uncomparable results. So it can be concluded that Lipiget cannot be used in replacement of Lipitor.
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