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Abstract

Single Dose Bioequivalence Study Of Two Brands Of Chloroquine Phosphate Tablets Using Salivary Kinetics

Author(s): C Jayanathi, C Rishiraj, Harsha B Patel, D. S Rajan, B Suresh

The present study was undertaken to evaluate the feasibility of salivary kinetics of chloroquine as an approach to biopharmaceutical and pharmacokinetic assessment and to test the bioequivalency of two marketed brands of chloroquine phosphate tablets using noninvasive saliva sampling technique. Pharmacokinetic parameters were computed following oral administration of a single dose of 600 mg of chloroquine base (250 mgx4 chloroquine phosphate tablets) to ten human healthy volunteers. All volunteers received 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 formulation, B was found to be in the range of 84-115%. No adverse reactions were observed during the entire study except for mild dizziness in 70% of the volunteers.

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