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NCT05525910 · ClinicalTrials.gov registry record · Phase 1
Relative Bioavailability Study of Nirmatrelvir/Ritonavir 4 Different Fixed Dose Combination Tablets Relative to the Commercial Tablets in Healthy Participants
A Phase 1 study of Healthy Participants and Biological Availability, sponsored by Pfizer.
- Completed
- Registry status
- Phase 1
- Development phase
- 15
- Enrollment target
- 1
- Study location
NCT05525910: Completed Phase 1 study of Healthy Participants and Biological Availability, sponsored by Pfizer.
NCT05525910 is a Phase 1 study of Healthy Participants and Biological Availability that has completed, run by Pfizer. The registered enrollment target is 15 participants, below the 66-participant average among 119 other Healthy Participants trials with a reported enrollment target (77% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05525910, a Phase 1 study of Healthy Participants and Biological Availability, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 15 participants
- Enrollment target
- 1
- Study location
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.
Primary Outcome
AUCinf was defined as area under the plasma concentration-time profile from time 0 extrapolated to infinite time. AUCinf for nirmatrelvir was calculated by AUClast + (Clast/kel), where Clast was the predicted plasma concentration at the last quantifiable time point from the log-linear regression analysis and kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration time curve.
Conditions Studied
Interventions
- DRUG Nirmatrelvir/ ritonavir
- DRUG Nirmatrelvir/ritonavir
Study Locations (1)
Connecticut
- New Haven Clinical Research Unit - New Haven
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2022-08-31 |
| Est. Completion | 2022-11-07 |
| Phase | Phase 1 |
What the finished NCT05525910 record still lists
NCT05525910 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 66-participant average among 119 other Healthy Participants trials with a reported enrollment target (77% lower).
The record links to 2 conditions, with Healthy Participants appearing as the primary indexed condition, and to 2 interventions - of which Nirmatrelvir/ ritonavir is the first listed.
NCT05525910 reports a single indexed study location in Connecticut.
Frequently Asked Questions
What is clinical trial NCT05525910 about?
NCT05525910 is a clinical study titled "Relative Bioavailability Study of Nirmatrelvir/Ritonavir 4 Different Fixed Dose Combination Tablets Relative to the Commercial Tablets in Healthy Participants". 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.
What is the current status of trial NCT05525910?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 15 participants. The study started on 2022-08-31. Estimated completion is 2022-11-07.
What conditions does trial NCT05525910 study?
This clinical trial studies the following conditions: Healthy Participants, Biological Availability.
What interventions are being tested in trial NCT05525910?
The interventions under investigation include: Nirmatrelvir/ ritonavir (DRUG), Nirmatrelvir/ritonavir (DRUG).
Who is sponsoring clinical trial NCT05525910?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05525910 being conducted?
This trial has 1 study location across Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05525910's enrollment target sits among peer trials
15 105th of 119 higher than 14 of 119 other Healthy Participants trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy Participants trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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