NCT05525910

Relative Bioavailability Study of Nirmatrelvir/Ritonavir 4 Different Fixed Dose Combination Tablets Relative to the Commercial Tablets in Healthy Participants

A Phase 1, Open-Label, Randomized, Single Dose, Crossover Study to Estimate the Relative Bioavailability of Nirmatrelvir and Ritonavir Following Oral Administration of 4 Different Fixed Dose Combination Tablet Formulations Relative to The Commercial Tablet Formulation in Healthy Adult Participants Under Fasted Conditions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (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 nirmatrelvir/ritonavir of 4 different FDC tablet formulations relative to the commercial tablet formulation under fasted conditions in healthy adult participants.

Conditions

• Biological Availability
• Healthy Participants

Interventions

Type	Name	Description
DRUG	Nirmatrelvir/ ritonavir	Single oral dose of nirmatrelvir/ritonavir tablets under fasted condition
DRUG	Nirmatrelvir/ritonavir	Single oral dose of nirmatrelvir/ritonavir tablets under fasted condition
DRUG	Nirmatrelvir/ritonavir	Single oral dose of nirmatrelvir/ritonavir tablets under fasted condition
DRUG	Nirmatrelvir/ ritonavir	Single oral dose of nirmatrelvir/ritonavir tablets under fasted condition
DRUG	Nirmatrelvir/ ritonavir	Single oral dose of nirmatrelvir/ritonavir tablets under fasted condition

Timeline

• Start date: 2022-08-31
• Primary completion: 2022-11-07
• Completion: 2022-11-07
• First posted: 2022-09-02
• Last updated: 2024-09-19
• Results posted: 2024-09-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study