BIOEQUIVALENCE STUDY OF AZELNIDIPINE 16 MG TABLET TO EVALUATE PHARMACOKINETIC PROFILE OF SINGLE DOSE IN HEALTHY, ADULT, HUMAN VOLUNTEERS UNDER FASTING CONDITION

DIBYA DAS; DHIMAN HALDER; ANIRBANDEEP BOSE; CHIRANJIT SAHA; HIMANGSHU SEKHAR MAJI; TAPAN KUMAR PAL

doi:10.22159/ijap.2021v13i4.41331

Authors

DIBYA DAS Department of Pharmaceutical Technology, JIS University, Kolkata 700109
DHIMAN HALDER Bioequivalence Study Centre, Jadavpur University, Kolkata 700032
ANIRBANDEEP BOSE TAAB Biostudy Services, Kolkata 700032
CHIRANJIT SAHA TAAB Biostudy Services, Kolkata 700032
HIMANGSHU SEKHAR MAJI Department of Pharmaceutical Technology, JIS University, Kolkata 700109
TAPAN KUMAR PAL Bioequivalence Study Centre, Jadavpur University, Kolkata 700032

DOI:

https://doi.org/10.22159/ijap.2021v13i4.41331

Keywords:

Bioequivalence study, Pharmacokinetic, Azelnidipine, Human volunteers, Fasting condition

Abstract

Objective: The present study's objective is to conduct a comparative bioavailability study with a special emphasis on the test product's bioequivalence using a standard reference product as a comparator.

Methods: Before initiating the bioequivalence study, the plasma sample analysis method was developed and validated by using LC-MS/MS method. The entire study was conducted as a single-dose crossover randomized bioequivalence study with open-label, two treatment, two-period, and two sequences on 24 healthy volunteers under fasting condition. With proper informed consent process the oral dose of the Reference product (R) or Test product (T) was administered on healthy volunteers at 0 h during each period of the study. After the drug's oral administration, a certain quantity of blood sample was collected, and the plasma sample was separated using a cold centrifuge. The plasma samples were analysed by using the validated LC-MS/MS method. The pharmacokinetic parameters, statistical data and ANOVA of the test and reference product were evaluated.

Results: The Cmax, Auc0-t, AUC0-∞ and t_max of the test product were found to be 6.29 ng/ml, 117.0 ng. h/ml, 161.67 ng. h/ml and 3.33 h. respectively. And the Cmax, Auc0-t, AUC0-∞ and t_max of reference product were found 6.59 ng/ml, 123.21 ng. h./ml, 172.20 ng. h/ml and 3.38 h respectively. Relative bioavailability was found 94.96%. The overall results show that the 90% confidence intervals (Log-Transformed and Untransformed) for Cmax, AUC0-t and AUC0-∞ for Azelnidipine were within the acceptable limit of 80%-125%.

Conclusion: The entire study's conclusion can be drawn as the test product was bioequivalence with the reference product's comparator.

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