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| Abstract: |
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The objective of the study was to
obtain the pharmacokinetic data of four marketed tablet formulations of
sparfloxacin and compare the relative bioavailability of the formulations with
standard formulation. A single dose 4 × 4 latin square design of the four
marketed tablet formulations of sparfloxacin (200 mg) was carried out in four
healthy male volunteers. Blood samples were collected at predetermined time
intervals. The serum concentrations of the drug were determined by
microbiological assay. The pharmacokinetic parameters were calculated from the
plasma concentration of sparfloxacin versus time data. The AUC0-a
of the
sparfloxacin from products A, B, C and D was 23.33
±
3.90 mg
h/ml, 19.72 ±
2.47 mg
h/ml, 18.76 ±
5.19 mg
h/ml and 18.27 ±
2.84 mg
h/ml respectively. The Cmax and t1/2 of the sparfloxacin
was 0.98 ±
0.07 mg/ml,
14.91 ±
1.30 h, 0.80 ±
0.06 mg/ml,
15.75 ±
2.37 h, 0.78 ±
0.11 mg/ml,
16.01 ±
1.98 and 0.81 ±
0.04 mg/ml,
13.91 ±3.59
h respectively for the products A, B, C and D. The serum concentration of the
sparfloxacin and other pharmacokinetic parameters obtained were statistically
analyzed. The results of three-way analysis of variance of serum drug levels
and pharmacokinetic parameters showed that there was no significant variation
between the products, subjects and treatments at all the points of time with
regard to the AUC0-a,
Cmax and t1/2. The results of the study indicated that
the products A, B, C and D are bioequivalent.
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