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brands of clarithromycin tablets (500 mg) in healthy Pakistani male volunteers.
Methodology: The study was performed using a randomized, open labeled,
two treatment periods and cross over study design. Healthy volunteers (n =12)
were recruited following strict inclusion criteria. Their blood samples were collected
at various time intervals over a period of 24 hrs after oral administration
of test and reference formulations of clarithromycin tablets (500 mg). A validated
reversed-phase high performance liquid chromatographic method with
ultraviolet detection (RP-HPLC-UV) was used for the quantification of plasma
concentrations of clarithromycin. Various pharmacokinetic parameters were determined
using non-compartmental analysis approach.
Results: The Cmax, tmax, AUC0âˆ’t and half-life (t1/2) values of clarithromycin from
test formulation were 2.882 ±0.13 Î¼g/mL, 1.75 ±0.45 hr, 11.33 ±0.68 Î¼g.hr/mL
and 2.84 ±0.17 hr, while for reference formulation these were 3.089 ±0.19 Î¼g/
mL, 1.83 ±0.39 hr, 12.87 ±1.09 Î¼g.hr/mL and 3.10 ±0.28 hr, respectively. The
90% confidence interval values of Cmax, tmax, AUC0-t and half life for test and reference
formulations of clarithromycin were 0.89-0.98, 0.80-1.14, 0.84-0.93 and
0.88-0.95, respectively, which satisfied the acceptance ranges of WHO and FDA
bioequivalence guidelines i.e., 0.80-1.25. Similarly, in-vitro evaluation studies
were also performed for both test and reference formulations of clarithromycin
as specified in the official monographs in USP-30. Both formulations qualified
all the in-vitro tests as per specifications in their respective monographs. The
f1 and f2 values were also within the acceptance ranges for test and reference
Conclusion: The test and reference formulations of clarithromycin were bioequivalent.
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