BIOEQUIVALENCE EVALUATION OF TWO CLARITHROMYCIN TABLET FORMULATIONS: A RANDOMIZED, SINGLE-DOSE, OPEN-LABEL, TWO-TREATMENT PERIOD CROSS OVER STUDY IN HEALTHY MALE PAKISTANI VOLUNTEERS
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Published:
May 12, 2017
Keywords:
Bioequivalence, Clarithromycin, RP-HPLC-UV, Pharmacokinetics
Main Article Content
Abstract
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.
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.
Article Details
How to Cite
1.
Samiullah ., Iqbal Z, Shah Y, Khan MI, Khan A, Nazar Z, 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 [Internet]. 2017 May 12 [cited 2024 Nov. 21];31(2). Available from: https://jpmi.org.pk/index.php/jpmi/article/view/2036
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