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of 17 subjects were analyzed and one subject was withdrawn due to vomiting.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.
