International Journal For Multidisciplinary Research

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Oral Bioequivalence Study Of Dapagliflozin 10 Mg And Rosuvastatin 20 Mg Tablet In Healthy Indian Subjects Under Fasting Conditions

Author(s) Rahul Kapse, Swarali Bhakare, Deepak Bagde, Prashant Kumthekar, Mihir Upadhyay, Vishwas Pukale
Country India
Abstract The objective to conduct this study is to compare the rate and extent of absorption and also to monitor the safety and tolerability of a single dose of Dapagliflozin 10 mg and Rosuvastatin 20 mg Tablets using Open label, balanced, randomized single-dose, two-treatment, two-sequence, two-period two-way Crossover design in 24 Healthy, Adult, Human Subjects Under Fasting Conditions. All subjects were dosed with the one tablet of Test product (T): Dapagliflozin 10 mg and Rosuvastatin 20 mg Tablet or reference product (R): Forxiga® 10 mg (Dapagliflozin 10 mg Tablets) and Rosulip 20 (Rosuvastatin 20 mg Tablets orally while in sitting position with 240 mL of 20% aqueous glucose solution as per the randomization schedule at ambient temperature. The LC-MS/MS method was developed at Bion Clinicals Pvt. Ltd., Pune, India to determine Plasma concentrations of Dapagliflozin and Rosuvastatin.
The result showed ratios of geometric least squares means of the test product (T) and reference product (R) for the Ln-transformed pharmacokinetic parameters Cmax, AUC0-t and AUC0-∞ of Dapagliflozin were found to be 93.21%, 97.09% and 96.12% respectively and for Rosuvastatin were found to be 101.29%, 100.91% and 99.39%.
The 90% confidence intervals for the ratios of geometric least squares means for the Ln-transformed pharmacokinetic parameters Cmax, AUC0-t and AUC0-∞ of Dapagliflozin were found to be 84.38% -102.97%, 93.45% -100.88% and 92.60%-99.78% respectively.
The 90% confidence intervals for the ratios of geometric least squares means for the Ln-transformed pharmacokinetic parameters Cmax, AUC0-t and AUC0-∞ of Rosuvastatin were found to be 91.53%-112.09%, 91.39%-111.43% and 88.16%-112.04% respectively.
In conclusion, the 90% confidence intervals of the differences of least squares means for the Ln-transformed pharmacokinetic parameters Cmax, AUC0-t and AUC0-∞ of Dapagliflozin and Rosuvastatin were within the bioequivalence acceptance limits of 80.00 - 125.00% and thus the test product (T): Dapagliflozin 10 mg and Rosuvastatin 20 mg Tablet and reference product (R): Forxiga® 10 mg (Dapagliflozin 10 mg Tablets) and Rosulip 20 (Rosuvastatin 20 mg Tablets) were found bioequivalent with respect to rate and extent of absorption. The Dapagliflozin 10 mg and Rosuvastatin 20 mg oral dose was well tolerated and was found safe.
Keywords Pharmacokinetic, Pharmacodynamic, Dapagliflozin, Rosuvastatin
Field Medical / Pharmacy
Published In Volume 7, Issue 1, January-February 2025
Published On 2025-01-18
Cite This Oral Bioequivalence Study Of Dapagliflozin 10 Mg And Rosuvastatin 20 Mg Tablet In Healthy Indian Subjects Under Fasting Conditions - Rahul Kapse, Swarali Bhakare, Deepak Bagde, Prashant Kumthekar, Mihir Upadhyay, Vishwas Pukale - IJFMR Volume 7, Issue 1, January-February 2025. DOI 10.36948/ijfmr.2025.v07i01.35437
DOI https://doi.org/10.36948/ijfmr.2025.v07i01.35437
Short DOI https://doi.org/g82gnc
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