NCT05263921

Relative Bioavailability Study of PF-07321332/Ritonavir Oral Powder Relative to the Commercial Tablets in Healthy Participants

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Bioavailability

Interventions

Type	Name	Description
DRUG	PF-07321332/ritonavir	Single oral dose of PF-07321332/ritonavir under fasted conditions
DRUG	PF-07321332/ritonavir	Single oral dose of PF-07321332/ritonavir mixed with water under fasted conditions
DRUG	PF-07321332/ritonavir	Single oral dose of PF-07321332/ritonavir mixed with applesauce under fasted conditions
DRUG	PF-07321332/ritonavir	Single oral dose of PF-07321332/ritonavir mixed with vanilla pudding under fasted conditions

Timeline

• Start date: 2022-03-10
• Primary completion: 2022-05-19
• Completion: 2022-05-19
• First posted: 2022-03-03
• Last updated: 2024-06-06
• Results posted: 2024-06-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study