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

NCT05525910 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2024-09-19

Study results available
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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

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

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
2022-08-31
Primary Completion
2022-11-07
Completion
2022-11-07
FDA Drug
Yes

Countries

  • United States

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 NCT05525910 on ClinicalTrials.gov