Samiullah, Zafar Iqbal, Yasar Shah, Muhammad Imran Khan, Abad Khan, Zahid Nazar, Obaidullah.
Bioequivalence Evaluation Of Two Clarithromycin Tablet Formulations: A Randomized, Single-Dose, Open-Label, Two-Treatment Period Cross Over Study In Healthy Male Pakistani Volunteers.
J Postgrad Med Inst Jan ;31(2):176-83.
Objective: To conduct the bioequivalence study of commercially available two 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, AUC0−t and half-life (t1/2) values of clarithromycin from test formulation were 2.882 ±0.13 μg/mL, 1.75 ±0.45 hr, 11.33 ±0.68 μg.hr/mL and 2.84 ±0.17 hr, while for reference formulation these were 3.089 ±0.19 μg/ mL, 1.83 ±0.39 hr, 12.87 ±1.09 μg.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 formulations. Conclusion: The test and reference formulations of clarithromycin were bioequivalent.
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