Bioequivalence study of a fixed-dose combination of Dapagliflozin/ Vildagliptin Sustained Release tablets in healthy adult male subjects: A Randomized, Open-Label, Crossover Study

  • Ameya Joshi Director, Diabetes and Endocrine Clinics, Mumbai
  • Ashish Birla Scientific Services, USV Private Limited, Mumbai, Maharashtra, India
  • Ashish Prasad Scientific Services, USV Private Limited, Mumbai, Maharashtra, India
  • Sona Warrier Scientific Services, USV Private Limited, Mumbai, Maharashtra, India

Abstract

A fixed-dose combination (FDC) of Dapagliflozin and Vildagliptin sustained release (SR) was developed, and its bioequivalence with coadministration of the individual tablets was evaluated in an open-label, randomized, two-treatment, two sequences, two-period, cross-over single-dose study. The study's primary objective was to compare and assess the rate and extent of absorption of Dapagliflozin 10 mg /Vildagliptin SR 100 mg FDC with individual drugs. Twenty-four healthy subjects were randomized, and 23 completed the study. For both Dapagliflozin and Vildagliptin SR, the 90% confidence intervals (CIs) for the ratio (Test product: Reference product) of geometric means of peak plasma concentration (Cmax), the area under the curve from 0 hours to the last measurable concentration (AUC0-t), and AUC-time curve up to infinity (AUC0-∞), were within acceptance criteria for bioequivalence, i.e., 80% to 125%. Overall, both reference and test products were safe and well tolerated.


Keywords: Bioequivalence, Dapagliflozin, Fixed-dose combination, Pharmacokinetic, Sustained release, Vildagliptin, Type 2 diabetes

Keywords: Bioequivalence, Dapagliflozin, Fixed-dose combination, Pharmacokinetic, Sustained release, Vildagliptin, Type 2 diabetes

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Author Biographies

Ameya Joshi, Director, Diabetes and Endocrine Clinics, Mumbai

Director, Diabetes and Endocrine Clinics, Mumbai

Ashish Birla, Scientific Services, USV Private Limited, Mumbai, Maharashtra, India

Scientific Services, USV Private Limited, Mumbai, Maharashtra, India

Ashish Prasad, Scientific Services, USV Private Limited, Mumbai, Maharashtra, India

Scientific Services, USV Private Limited, Mumbai, Maharashtra, India

Sona Warrier, Scientific Services, USV Private Limited, Mumbai, Maharashtra, India

Scientific Services, USV Private Limited, Mumbai, Maharashtra, India

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Joshi A, Birla A, Prasad A, Warrier S. Bioequivalence study of a fixed-dose combination of Dapagliflozin/ Vildagliptin Sustained Release tablets in healthy adult male subjects: A Randomized, Open-Label, Crossover Study. JDDT [Internet]. 15Nov.2022 [cited 9Dec.2022];12(6):105-9. Available from: https://jddtonline.info/index.php/jddt/article/view/5798