Trials / Completed
CompletedNCT05544786
Relative Bioavailability Study of Nirmatrelvir/Ritonavir Oral Powder Relative to the Commercial Tablets and Estimation of the Effect of Food on Bioavailability of the Nirmatrelvir/Ritonavir Oral Powder in Healthy Participants.
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
- 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 (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.
Conditions
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 mixed in water under fasted condition |
| DRUG | Nirmatrelvir/Ritonavir | Single oral dose of nirmatrelvir/ritonavir mixed in infant formula under fasted condition |
| DRUG | Nirmatrelvir/ritonavir | Single oral dose of nirmatrelvir/ritonavir mixed in vanilla pudding under fasted condition |
| DRUG | Nirmatrelvir/ritonavir | Single oral dose of nirmatrelvir/ritonavir mixed in vanilla pudding under fed condition |
Timeline
- Start date
- 2022-09-28
- Primary completion
- 2022-11-29
- Completion
- 2022-11-29
- First posted
- 2022-09-16
- Last updated
- 2024-05-10
- Results posted
- 2024-05-10
Locations
1 site across 1 country: Belgium
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05544786. Inclusion in this directory is not an endorsement.