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Bioequivalence Studies Of Two Formulations Of Acyclovir Sodium Tablets

Author(s): Shivprakash, B Khamar, I. S Rathod, D. D Santani

The objective was to compare the bioavailability of two tablet dosage forms of acyclovir in human volunteers. Serum levels of acyclovir was determined by using high performance liquid chromatography. The pharmacokinetic parameters were estimated following the oral administration of a single dose (200 mg) tablet of the drug to 12 healthy volunteers. All volunteers received a single oral dose of the medication in a two period, two way cross-over design. The difference between the formulations were statistically insignificant. In all the cases the relative bioavailability of the test was found to be in the range of 83-106 %. No adverse reactions were observed during the entire study. The test formulation manufactured by Cadila Laboratories Pvt. Ltd., was found to be bioequivalent to the reference product.


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