Phase I Randomized Crossover Bioequivalence Study of Nirmatrelvir and Ritonavir Tablets in Healthy Adult Volunteers Under Fasting Conditions
Dr. M. Narender, Dr. K. Ramulu, Clinical Research, Hyderabad.
DOI: https://doi.org/10.63712/bpsrj-v2i2p001
ABSTRACT:
This study was conducted to evaluate the bioequivalence of a test formulation of Nirmatrelvir 300 mg (2 × 150 mg tablets) combined with Ritonavir 100 mg compared with the reference product Paxlovid in healthy adult human subjects under fasting conditions. The study was an open-label, randomized, balanced, two-treatment, four-period, two-sequence, full replicate crossover design. A total of 44 healthy adult male subjects were enrolled and received a single oral dose of either the test or reference product. Pharmacokinetic parameters such as Cmax and AUC0–t were evaluated to determine bioequivalence. Safety and tolerability were also assessed during the study. The results demonstrated that the test product was bioequivalent to the reference product as the 90% confidence intervals for the primary pharmacokinetic parameters were within the accepted regulatory limits of 80.00%–125.00%.