Camber's Warfarin Sodium Tablets, USP
Demonstrate superior bioequivalence with Coumadin® through cross-over studies.
Demonstrate superior bioequivalence with Coumadin® through cross-over studies.
Below is the information of two-way, single dose studies of Camber's Warfarin Sodium Tablets, USP 10 mg in comparison to Coumadin® 10mg.
Mean Warfarin Plasma concentration (ng/mL) in Fasted Subjects after 10 mg dose
R = Coumadin® T = Warfarin Sodium Tablets, USP 10mg
Comments:
- Warfarin Sodium Tablets, USP 10 mg formulation is bioequivalent to the Coumadin® tablet 10mg.
- The 90% confidence intervals are very close in range leading to superior dose titration.
- Warfarin Sodium Tablets, USP 1, 2, 2.5, 3, 4, 5, 6, 7.5 and 10 mg exhibit similar in-vitro drug release profiles to Coumadin Tablets.
- Camber's formulation has consistent dose delivery with tight control on the process.
Comparison of Coumadin
Physical Equivalency
