Journal of Bioequivalence & Bioavailability

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Publications

• Research Article   
  A Healthy Participant Study to Evaluate the Bioequivalence of Form H and Form II Tablets of the Smallpox Antiviral Brincidofovir
  Author(s): David M Cassie*, Vanja Komlenovic, James McCarty, Jing Tian and Kevin Yeo
  
  Background: Brincidofovir (BCV) is approved in the US and Canada for the treatment of human smallpox disease in adults and children, including neonates. In long-term storage, the commercially available BCV morphic Form II is slowly converted to a hydrated morphic Form H, which is more stable under ambient conditions. The purpose of this study (NCT05935917) was to compare the Bioequivalence (BE) of the morphic Forms II and H. Methods: This was a Phase 1, open-label, randomized, two-period crossover study completed in healthy adults randomized to receive either a single 100 mg BCV Form II or Form H tablet and followed for 14 days after each dose to assess Pharmacokinetics (PK) and safety. The primary PK endpoints for demonstration of BE were Cmax , AUClast , and AUCinf of BCV in plasma. BE was declared if the 9.. View more»
  

  DOI: 10.35248/0975-0851.25.17.626

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