Mon, 20 Nov 2017

A Randomized, Single Dose Bioequivalence Study of Two Tablet Formulations of Balofloxacin In Healthy Human Subjects Under Fasting Conditions

Prabhavathi K1*, JC Shobha1,  Radhika S1

1.Department of Clinical Pharmacology and Therapeutics, Nizam's Institute of Medical Sciences (NIMS), Hyderabad


ABSTRACT

To compare the bioavailability of two tablet formulations of Balofloxacin 100 mg in adult, male, healthy human subjects under fasting conditions.The study was conducted as an open label, balanced, randomized, two-period, two-sequence, two treatment, single dose cross over study to determine the bioequivalence of two tablet formulations of Balofloxacin 100 mg in 24 healthy, adult, male, human subjects under fasting conditions. Serial blood samples were collected at 0, 0.5, 1.0, 1.50, 2.0, 2.50, 2.75, 3.0, 3.25, 3.50, 3.75, 4.0, 4.50, 4.75, 5.0, 6.0, 8.0, 10.0, 12.0, 16.0, 24.0, 36.0, 48.0h during each study period. A washout period of 7 days was given between two study periods. 90% confidence interval(CI) for the ratio of logarithmic transformed pharmacokinetic parameters Cmax, Tmax, AUC0-t and AUC 0- ∞ were used to determine bioequivalence. The data of 23 subjects was analyzed in the study. Tmax (hrs),  Cmax (µg/ml),  AUC 0-t  and AUC0-∞ (µg.h/ml) for test formulation were 1.174±0.535 , 852.431±361.274, 4682.785±1616.552 and 5375.882±1727.286 and that of reference formulation were 1.033±0.428, 850.238±312.422, 4447.628±1240.125 and 5125.723±1304.619 respectively. The 90% CI for the T/R ratios of  log transformed  Cmax, AUC0-t and  AUC 0-∞ were 89.58%-108.19%, 98.86%-109.88% and 97.70%-110.01% respectively. The two tablet formulations of Balofloxacin 100mg (both test and reference) met the  requisite bioequivalence criteria (80-125%) .

Keywords: Bioequivalence, Balofloxacin, Urinary Tract Infection


[PDF]  Viewed: 954  Downloaded: 93
  • Call for paper

    American Journal of PharmTech Research (AJPTR) is a peer-reviewed, bimonthly official international journal allowing access to abstracts and full-text.

    Read more...

     

  • Email & SMS Alerts

    Email/SMS alert system is one of the key features and gives update information about the submitted manuscript.

    Read more...

  • Article Statastics

    American Journal of PharmTech Research (AJPTR) provides unique facility for authors to know popularity of articles on basis of numbers of PDF download and views. It will display in tabulated format.

  • Online Submission

    American Journal of PharmTech Research (AJPTR) is one of the International open access journal devoted to various disciplines in science and technology.

    Read more...

web counter
web counter