Treatment B: Nirmatrelvir/ ritonavir for Biological Availability

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
New Haven Clinical Research Unit, New Haven, CT
Biological Availability+1 More
Nirmatrelvir/ritonavir - Drug
Eligibility
18+
All Sexes
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Study 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.

Eligible Conditions

  • Biological Availability
  • Healthy Subjects (HS)

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Biological Availability

Study Objectives

2 Primary · 5 Secondary · Reporting Duration: 0 , 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours

Hour 72
Area under curve from time zero to 72 hours post dose
Peak plasma concentration (Cmax)
Day 28
Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs)
Day 4
Number of Participants With Clinically Notable Abnormality in physical examination
Number of Participants With Clinically Notable Changes in Clinical laboratory
Number of Participants With Clinically Notable Vital Signs
Number of Participants With Notable Electrocardiogram (ECG) Values

Trial Safety

Safety Progress

1 of 3

Other trials for Biological Availability

Trial Design

5 Treatment Groups

Treatment A: Nirmatrelvir/ritonavir
1 of 5
Treatment B: Nirmatrelvir/ ritonavir
1 of 5
Treatment D: Nirmatrelvir/ ritonavir
1 of 5
Treatment C: Nirmatrelvir/ ritonavir
1 of 5
Treatment E: Nirmatrelvir/ ritonavir
1 of 5
Active Control
Experimental Treatment

15 Total Participants · 5 Treatment Groups

Primary Treatment: Treatment B: Nirmatrelvir/ ritonavir · No Placebo Group · Phase 1

Treatment B: Nirmatrelvir/ ritonavir
Drug
Experimental Group · 1 Intervention: Nirmatrelvir/ritonavir · Intervention Types: Drug
Treatment D: Nirmatrelvir/ ritonavir
Drug
Experimental Group · 1 Intervention: Nirmatrelvir/ ritonavir · Intervention Types: Drug
Treatment C: Nirmatrelvir/ ritonavir
Drug
Experimental Group · 1 Intervention: Nirmatrelvir/ritonavir · Intervention Types: Drug
Treatment E: Nirmatrelvir/ ritonavir
Drug
Experimental Group · 1 Intervention: Nirmatrelvir/ ritonavir · Intervention Types: Drug
Treatment A: Nirmatrelvir/ritonavir
Drug
ActiveComparator Group · 1 Intervention: Nirmatrelvir/ ritonavir · Intervention Types: Drug

Trial Logistics

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 0 , 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours
Closest Location: New Haven Clinical Research Unit · New Haven, CT
Photo of New Haven  1Photo of New Haven  2Photo of New Haven  3
2015First Recorded Clinical Trial
1 TrialsResearching Biological Availability
47 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 3 Total Inclusion Criteria

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About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.