Comparative Bioavailability of Four Marketed Sparfloxacin Formulations in Healthy Human Volunteers
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 sparfloxaci...
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| Format: | Article |
| Language: | English |
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Wiley
2004-01-01
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| Series: | E-Journal of Chemistry |
| Online Access: | http://dx.doi.org/10.1155/2004/879208 |
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| author | K. Ravindra Rao J. Vijaya Ratna T. Manikya Rao |
| author_facet | K. Ravindra Rao J. Vijaya Ratna T. Manikya Rao |
| author_sort | K. Ravindra Rao |
| collection | DOAJ |
| description | 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-α of the sparfloxacin from products A, B, C and D was 23.33±3.90 μg h/mL, 19.72±2.47 μg h/mL, 18.76±5.19 μg h/mL and 18.27±2.84 μg h/mL respectively. The Cmax and t1/2 of the sparfloxacin was 0.98±0.07 μg/mL, 14.91±1.30 h, 0.80±0.06 μg/mL, 15.75±2.37 h, 0.78±0.11 μg/mL, 16.01±1.98 and 0.81±0.04 μg/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-α, Cmax and t1/2. The results of the study indicated that the products A, B, C and D are bioequivalent. |
| format | Article |
| id | doaj-art-7bba224acbd7423dab365f36c8367d69 |
| institution | Kabale University |
| issn | 0973-4945 2090-9810 |
| language | English |
| publishDate | 2004-01-01 |
| publisher | Wiley |
| record_format | Article |
| series | E-Journal of Chemistry |
| spelling | doaj-art-7bba224acbd7423dab365f36c8367d692025-02-03T01:23:51ZengWileyE-Journal of Chemistry0973-49452090-98102004-01-0111435010.1155/2004/879208Comparative Bioavailability of Four Marketed Sparfloxacin Formulations in Healthy Human VolunteersK. Ravindra Rao0J. Vijaya Ratna1T. Manikya Rao2Department of Pharmaceutica Sciences, Andhra University, Visakhapatnam-530 003, IndiaDepartment of Pharmaceutica Sciences, Andhra University, Visakhapatnam-530 003, IndiaDepartment of Pharmaceutica Sciences, Andhra University, Visakhapatnam-530 003, IndiaThe 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-α of the sparfloxacin from products A, B, C and D was 23.33±3.90 μg h/mL, 19.72±2.47 μg h/mL, 18.76±5.19 μg h/mL and 18.27±2.84 μg h/mL respectively. The Cmax and t1/2 of the sparfloxacin was 0.98±0.07 μg/mL, 14.91±1.30 h, 0.80±0.06 μg/mL, 15.75±2.37 h, 0.78±0.11 μg/mL, 16.01±1.98 and 0.81±0.04 μg/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-α, Cmax and t1/2. The results of the study indicated that the products A, B, C and D are bioequivalent.http://dx.doi.org/10.1155/2004/879208 |
| spellingShingle | K. Ravindra Rao J. Vijaya Ratna T. Manikya Rao Comparative Bioavailability of Four Marketed Sparfloxacin Formulations in Healthy Human Volunteers E-Journal of Chemistry |
| title | Comparative Bioavailability of Four Marketed Sparfloxacin Formulations in Healthy Human Volunteers |
| title_full | Comparative Bioavailability of Four Marketed Sparfloxacin Formulations in Healthy Human Volunteers |
| title_fullStr | Comparative Bioavailability of Four Marketed Sparfloxacin Formulations in Healthy Human Volunteers |
| title_full_unstemmed | Comparative Bioavailability of Four Marketed Sparfloxacin Formulations in Healthy Human Volunteers |
| title_short | Comparative Bioavailability of Four Marketed Sparfloxacin Formulations in Healthy Human Volunteers |
| title_sort | comparative bioavailability of four marketed sparfloxacin formulations in healthy human volunteers |
| url | http://dx.doi.org/10.1155/2004/879208 |
| work_keys_str_mv | AT kravindrarao comparativebioavailabilityoffourmarketedsparfloxacinformulationsinhealthyhumanvolunteers AT jvijayaratna comparativebioavailabilityoffourmarketedsparfloxacinformulationsinhealthyhumanvolunteers AT tmanikyarao comparativebioavailabilityoffourmarketedsparfloxacinformulationsinhealthyhumanvolunteers |