At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A PHASE 1, OPEN-LABEL, RANDOMIZED, SINGLE DOSE, CROSSOVER STUDY TO ESTIMATE THE RELATIVE BIOAVAILABILITY OF NIRMATRELVIR (PF-07321332) /RITONAVIR ORAL POWDER IN 3 DIFFERENT FOOD DELIVERY VEHICLES RELATIVE TO THE NIRMATRELVIR (PF-07321332) /RITONAVIR COMMERCIAL TABLETS UNDER FASTED CONDITIONS, AND THE EFFECT OF FOOD ON RELATIVE BIOAVAILABILITY OF NIRMATRELVIR (PF-07321332) /RITONAVIR ORAL POWDER IN HEALTHY ADULT PARTICIPANTS
In Brief
A Phase 1 clinical trial evaluating Nirmatrelvir/ ritonavir, Nirmatrelvir/Ritonavir, and 1 other intervention for Biological Availability. Completed, enrolled 12 participants across 1 site.
Detailed Summary
The purpose of this study is to estimate the relative bioavailability (rBA) of nirmatrelvir/ritonavir oral powder in 3 different food vehicles relative to the Paxlovid® tablets under fasted condition in healthy adult participants, and to estimate the effect of food on the rBA of the nirmatrelvir/ritonavir oral powder formulation. The study will also assess the safety, tolerability, and palatability of nirmatrelvir/ritonavir oral powder in healthy adult participants.
Study Details
Timeline
Interventions
Single oral dose of nirmatrelvir/ritonavir tablets under fasted condition
Single oral dose of nirmatrelvir/ritonavir mixed in water under fasted condition
Single oral dose of nirmatrelvir/ritonavir mixed in infant formula under fasted condition
Single oral dose of nirmatrelvir/ritonavir mixed in vanilla pudding under fasted condition
Single oral dose of nirmatrelvir/ritonavir mixed in vanilla pudding under fed condition