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A Randomized, Two-Treatments, Two-Periods, Crossover, Open label, Laboratory-Blind, Single Dose Bioequivalence Study between Vildagliptin/Metformin 50 mg/1000 mg Film Coated Tablets (Sensityn®) and Galvusmet® 50 mg/1000 mg Film Coated Tablets in healthy adults under fed conditions

J. Shiekmydeen
J. Shiekmydeen
, 
T. Siddiqi
T. Siddiqi
, 
K. Chakraborty
K. Chakraborty
, 
S. Khalaf
S. Khalaf
, 
M. Albarazi
M. Albarazi
, 
I. Eqtefan
I. Eqtefan
 und 
J. Sliva
J. Sliva
   | 20. Okt. 2023
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Article Category: Original Paper
Online veröffentlicht: 20. Okt. 2023
Seitenbereich: 1 - 9
Eingereicht: 16. Aug. 2023
Akzeptiert: 30. Aug. 2023
DOI: https://doi.org/10.2478/afpuc-2023-0019
Schlüsselwörter
© 2023 J. Shiekmydeen et al., published by Sciendo
This work is licensed under the Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.

Figure 1.

Schematic chart of the study.
Schematic chart of the study.

Figure 2.

Vildagliptin mean plasma concentrations versus time for Sensityn® (--○--) and Galvusmet® (--▪--) after single oral dose administration to healthy adult human subjects under fed conditions
Vildagliptin mean plasma concentrations versus time for Sensityn® (--○--) and Galvusmet® (--▪--) after single oral dose administration to healthy adult human subjects under fed conditions

Figure 3.

Linear plot of metformin mean plasma concentrations versus time for Sensityn® (--○--) and Galvusmet® (--▪--) after single oral dose administration to healthy adult human subjects under fed conditions.
Linear plot of metformin mean plasma concentrations versus time for Sensityn® (--○--) and Galvusmet® (--▪--) after single oral dose administration to healthy adult human subjects under fed conditions.

Statistical comparisons of metformin pharmacokinetic parameters.

Primary PK parameter Number of subjects Intrasubject CV Geometric LS means Ratio 90% Confidence limits Power
Test product (Sensityn®) Reference product (Galvusmet®) Lower Upper
Cmax 36 13.12% 1398.75 1439.77 97.15 92.22 102.34 1.0000
AUC0-t 36 11.36% 12,936.80 13,158.66 98.31 93.97 102.85 1.0000
AUC0-∞ 35 10.99% 13,470.20 13,850.76 97.25 93.03 101.66 1.0000

Statistical comparisons of vildagliptin pharmacokinetic parameters.

Primary PK parameter Number of subjects Intrasubject CV Geometric LS means Ratio 90% Confidence limits Power
Test product (Sensityn®) Reference product (Galvusmet®) Lower Upper
Cmax 36 19.91% 73.87 71.09 103.90 96.05 112.40 0.9981
AUC0-t 36 10.12% 354.19 348.77 101.55 97.55 105.72 1.0000
AUC0-∞ 33 8.32% 375.66 369.50 101.67 98.20 105.25 1.0000

Summary of metformin pharmacokinetic parameters.

Pharmacokinetic parameter Test product (Sensityn®)(mean ± SD)N = 36 Reference product (Galvusmet®)(mean ± SD)N = 36
Cmax (ng/ml) 1448.13 ± 397.346 1479.84 ± 348.938
AUC0-t (h*ng/ml) 13,340.49 ± 3305.003 13,597.70 ± 3486.835
AUC0-∞ (h*ng/ml) 13,853.49 ± 3331.352 14,153.50 ± 3784.388
Thalf (h) 4.28 ± 0.519 4.52 ± 1.030
Kelimination, λz (h−1) 0.1640 ± 0.01948 0.1593 ± 0.02752
AUC_%Extrap_obs 3.41 ± 3.254 3.63 ± 3.095
Test product (Sensityn®)(median ± SD) (Min–Max)N = 36 Reference product (Galvusmet®)(median ± SD) (Min–Max)N = 36
Tmax(h) 4.00 ± 1.708 (1.00–8.00) 4.50 ± 1.331 (0.75–6.00)

Demographic data (N = 36).

Parameter Age (years) Height (m) Weight (kg) BMI (kg/m2)
Mean 29.0 1.74 76.0 24.90
SD 7.8 0.05 9.6 2.97
Min 18.0 1.62 58.0 20.30
Max 45.0 1.84 92.0 29.70

Summary of vildagliptin pharmacokinetic parameters.

Pharmacokinetic parameter Test product (Sensityn®)(mean ± SD)N = 36 Reference product (Galvusmet®)(mean ± SD)N = 36
Cmax (ng/ml) 76.54 ± 20.606 73.99 ± 21.526
AUC0-t (h*ng/ml) 358.56 ± 57.756 355.27 ± 69.553
AUC0-∞ (h*ng/ml) 378.17 ± 62.279 369.66 ± 68.677
Thalf (h) 2.22 ± 0.735 2.03 ± 0.567
Kelimination, λz (h−1) 0.3396 ± 0.09300 0.3706 ± 0.11124
AUC_%Extrap_obs 4.47 ± 5.142 3.19 ± 2.993
Test product (Sensityn®)(median ± SD) (Min-Max)N = 36 Reference product (Galvusmet®)(median ± SD) (Min-Max)N = 36
Tmax (h) 2.50 ± 1.553 (0.75–8.00) 2.50 ± 1.405 (0.50–5.00)
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