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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.

NCT05544786 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2024-05-10

Study results available
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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

  • Biological Availability

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-09-28
Primary Completion
2022-11-29
Completion
2022-11-29
FDA Drug
Yes

Countries

  • Belgium

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05544786 on ClinicalTrials.gov