A Phase 1 Study to Evaluate the Effect of Crushing, Cutting Into Half, or Grinding of Glecaprevir/Pibrentasvir Tablets on Exposures in Healthy Subjects

• Published in: Journal of pharmaceutical sciences Vol. 107; no. 6; pp. 1724 - 1730
• Main Authors: Oberoi, Rajneet K., Zhao, Weihan, Sidhu, Dilraj S., Viani, Rolando M., Trinh, Roger, Liu, Wei
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 01.06.2018
• Subjects: Adult; anti-infectives; Antiviral Agents - administration & dosage; Antiviral Agents - adverse effects; Antiviral Agents - blood; Area Under Curve; Benzimidazoles - administration & dosage; Benzimidazoles - adverse effects; Benzimidazoles - blood; bioavailability; Biological Availability; clinical pharmacokinetics; Cross-Over Studies; Female; formulation; Humans; Male; Middle Aged; oral absorption; Particle Size; pharmacokinetics; Quinoxalines - administration & dosage; Quinoxalines - adverse effects; Quinoxalines - blood; Sulfonamides - administration & dosage; Sulfonamides - adverse effects; Sulfonamides - blood; Tablets; GLE; Cmax; DAA; RBV; PIB; anti-infectives; GT; AUC; bioavailability; t1/2; Tmax; clinical pharmacokinetics; formulation; pharmacokinetics; HCV; oral absorption

Glecaprevir (GLE) and pibrentasvir (PIB) are direct-acting antivirals coformulated as a combination tablet for once-daily treatment of chronic hepatitis C virus infection. The objective of this study was to evaluate the effect of different methods of tablet manipulations–cutting in half, grinding in...