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Bioequivalence Studies Of Two Formulations Of Rivaroxaban 10 Mg Coated Tablets Under Fasting Conditions And 20 Mg Coated Tablets.pdf

9103-Bioequivalence-Studies.pdf
Preview of Bioequivalence Studies of Two Formulations of Rivaroxaban 10 Mg Coated Tablets under Fasting Conditions and 20 Mg Coated Tablets
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📊 Size: 385 KB
📄 Pages: 14 pages
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Summary

A bioequivalence study was conducted to compare two formulations of rivaroxaban (10mg and 20mg coated tablets) manufactured by Eurofarma Laboratórios S/A with the reference drug Xarelto (Bayer) under fasting and fed conditions. The study involved 48 healthy adult subjects and used a randomized, open-label, balanced, 2-treatment, 4-period, 2-sequence, single-dose, full replicate, crossover design. The results showed that the geometric mean ratio (90%CI) of the test/reference for rivaroxaban was within the acceptable range for AUC0-t, AUC0-inf, and Cmax, indicating bioequivalence between the two formulations. No serious or significant adverse events were observed during the study. The conclusion was that rivaroxaban 10mg and 20mg manufactured by Eurofarma Laboratórios S/A are statistically bioequivalent to the reference drug Xarelto (Bayer).

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Description

A bioequivalence study was conducted to compare two formulations of rivaroxaban (10mg and 20mg coated tablets) manufactured by Eurofarma Laboratórios S/A with...

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  • File Format: PDF
  • File Size: 385 KB
  • Pages: 14
  • Language: EN
  • Total Downloads: 354
  • Last Updated: 2 months ago

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