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A Randomized, Open Lable, Balanced, Two-Treatment, Two-Period, Two-Sequence, Single Dose, Crossover, Bioequivalence Study of Atorvastatin Calcium Tablet 80 mg in Normal, Healthy, Adult, Human Subjects Under Fasting Condition.

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dc.contributor.author PATEL, CHIRAG
dc.date.accessioned 2020-11-10T05:58:55Z
dc.date.available 2020-11-10T05:58:55Z
dc.date.issued 2012-05-01
dc.identifier.uri http://ir.paruluniversity.ac.in:8080/xmlui/handle/123456789/7554
dc.description For Full Thesis Kindly contact to respective Library en_US
dc.description.abstract Objective: The objective of present study was to carry out bioequivalence of Test Product: Atorvastatin Calcium 80 mg Tablet and Reference Product: Citalor (Atorvastatin Calcium 80 mg Tablet) of Pfizer Ireland Pharmaceuticals, under Fasting condition in normal, healthy, adult, human subjects, in a randomized, open label, crossover study. Experimental Work Done: Total 18 normal, healthy, adult, human subjects were enrolled. The subjects willingly signed the informed consent form before participating in the study. Single oral dose of test product or reference product was administered in each study period considering 07 days washout period. A total of 22 blood samples (5 ml each) were collected from the subjects during each study period. Analysis of plasma concentrations of Atorvastatin was done by a validated LCMS/MS analytical method. A non-compartmental method was used to calculate the pharmacokinetic parameters using drug concentration time profile. Statistical comparison of the pharmacokinetic parameters of both the formulations was performed to assess bioequivalence. Results And Discussion: In the study total 18 subjects were enrolled from which data of 17 subjects were analyzed and one subject was withdrawn due to vomiting. For test formulation versus the reference formulation, the least squares mean test/reference ratios of Ln(Cmax) and Ln(AUC0-t) were 96.59%,97.82%.The 90% confidence interval for logtransformed data of Test Product compared to that of the Reference Product was 83.59- 115.67% for Cmax and 82.63-115.79% for AUC0-t. In this study test formulation was found bioequivalent to the reference formulation as per predetermined regulatory criteria. Conclusion: Based on the statistical analysis of the results, it can be concluded that the Test Product Atorvastatin Calcium Tablet 80 mg is bioequivalent to the Reference Product in terms of rate and extent of absorption under fasting condition. As well as it is well tolerated and safe. en_US
dc.language.iso en en_US
dc.publisher Parul University en_US
dc.subject 102140803018 en_US
dc.title A Randomized, Open Lable, Balanced, Two-Treatment, Two-Period, Two-Sequence, Single Dose, Crossover, Bioequivalence Study of Atorvastatin Calcium Tablet 80 mg in Normal, Healthy, Adult, Human Subjects Under Fasting Condition. en_US
dc.title.alternative 102140803018 en_US
dc.type Thesis en_US


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