At a glance
ClinicalIndex Comparison Record- ✓Overtly healthy as determined by medical evaluation including medical history, physical exam, laboratory tests, vital signs, and standard 12-lead ECGs
- ✓BMI 17.5-30.5 kg/m² and total body weight >50 kg
- ✓Willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and study procedures
- ✕Positive SARS-CoV-2 test at screening or Day -1
- ✕History or evidence of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease
- ✕Clinically relevant cardiac abnormalities including acute MI, unstable ischemia, ventricular dysfunction, serious arrhythmias, prolonged PR interval, cardiomyopathy, heart failure >NYHA Class 1, structural heart disease, or Wolff-Parkinson-White syndrome
- ✕Any condition affecting drug absorption such as gastrectomy or cholecystectomy
Standardized 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 PF-07321332/RITONAVIR ORAL POWDER IN 3 DIFFERENT DELIVERY VEHICLES RELATIVE TO THE COMMERCIAL PF-07321332/RITONAVIR TABLETS IN HEALTHY ADULT PARTICIPANTS UNDER FASTED CONDITIONS
In Brief
A Phase 1 clinical trial evaluating PF-07321332/ritonavir for Bioavailability. Completed, enrolled 12 participants across 1 site.
Detailed Summary
The purpose of this study is to estimate the relative bioavailability of PF-07321332/ritonavir oral powder relative to the commercial tablet formulation under fasted condition in healthy adult participants. The study will also assess the effect of 3 different food vehicles on the relative bioavailability of the PF-07321332/ritonavir oral powder formulation as well as the safety, tolerability, and palatability of PF-07321332/ritonavir oral powder in healthy adult participants.
Study Details
Timeline
Interventions
Single oral dose of PF-07321332/ritonavir under fasted conditions
Single oral dose of PF-07321332/ritonavir mixed with water under fasted conditions
Single oral dose of PF-07321332/ritonavir mixed with applesauce under fasted conditions
Single oral dose of PF-07321332/ritonavir mixed with vanilla pudding under fasted conditions