Abstract

BIOEQUIVALENCE STUDY OF TWO ORAL CHLORTETRACYCLINE SOLUBLE POWDER (CHLORTETRACYCLINE C100 KS® AND CLORADAZAN®) IN BROILER CHICKENS

Ashraf Elkomy* and Mohamed Aboubakr

ABSTRACT

The present study was designed to assess the comparative bio-equivalence of Chlortetracycline C100 KS® and Cloradazan® in healthy broiler chickens after oral administration of both products in a dose of 20 mg chlortetracycline/Kg b.wt. Twenty four broiler chickens were divided into two groups. The first group was designed to study the pharmacokinetics of Chlortetracycline C100 KS®, while the 2nd group was designed to study the pharmacokinetics of Cloradazan®. Each broiler chicken in both groups was orally administered with 20 mg chlortetracycline/Kg b.wt. Blood samples were obtained from the wing vein and collected immediately before and at 0.08, 0.16, 0.25, 0.5, 1, 2, 4, 8, 12 and 24 hours after a single oral administration. The disposition kinetics of Chlortetracycline C100 KS® and Cloradazan® following oral administration of 20 mg chlortetracycline/Kg b.wt, revealed that the maximum blood concentration of chlortetracycline [Cmax] were 2.83 and 2.51 μg/ml and attained at [tmax] of 0.78 and 0.80 hours, respectively. In conclusion: Cloradazan® is bioequivalent to Chlortetracycline C100 KS® since the ratios of Cmax, AUC0-24 and AUC0-∞ (T/R) was 0.88, 0.95 and 0.94 respectively. These are within the bioequivalence acceptance range. Cloradazan® and Chlortetracycline C100 KS® are therefore bioequivalent and interchangeable.

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