Food Effect Study to Evaluate the Effect of High-Fat Meal on the Relative Bioavailability of PF-07321332 Boosted With Ritonavir in Healthy Adult Participants

Phase 1 Completed 12 enrolled Pfizer

RandomizedCrossoverOpen-labelBasic science

Summary

This is a Phase 1, open label, single dose, randomized, 2-treatment, 2-sequence, 2-period crossover study to evaluate the effect of high-fat meal on the relative bioavailability of PF-07321332 boosted with ritonavir following single dose oral administration of PF-07321332 in combination with ritonavir using 150 mg tablet formulation of PF-07321332 in healthy adult participants.

Timeline

Start: 2021-11-12
Primary completion: 2022-01-12
Completion: 2022-01-12

Publications

Sagawa K, Lin J, Jaini R, Di L. Physiologically-Based Pharmacokinetic Modeling of PAXLOVID with First-Order Absorption Kinetics. Pharm Res. 2023 Aug;40(8):1927-1938. doi: 10.1007/s11095-023-03538-5. Epub 2023 May 25.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Nirmatrelvir	Small molecule	300 mg	Oral
Background	Ritonavir	Other / unclassified	100 mg	Oral

Indications

No indication recorded.