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NCT05674721 · ClinicalTrials.gov registry record · Phase 1
A Bioequivalence Study of Advil PM Liqui-Gels Minis (Ibuprofen/Diphenhydramine Hydrochloride 200 mg/25 mg) Compared to the Current Marketed Advil PM Liqui-Gels (Ibuprofen/Diphenhydramine Hydrochloride 200 mg/25 mg) in Healthy Adult Subjects Under Fasted Conditions
A Phase 1 study, sponsored by HALEON.
- Completed
- Registry status
- Phase 1
- Development phase
- 77
- Enrollment target
NCT05674721: Completed Phase 1 study, sponsored by HALEON.
NCT05674721 is a Phase 1 study that has completed, run by HALEON. The registered enrollment target is 77 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (28% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05674721, a Phase 1 study, has completed, sponsored by HALEON.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 77 participants
- Enrollment target
Study Summary
The purpose of this study is to support the submission of Advil PM Liqui-Gels Minis (ibuprofen/diphenhydramine hydrochloride 200 milligrams \[mg\]/25 mg) which is a size reduction of the currently marketed Advil PM Liqui-Gels, by determining if this product is bioequivalent to the reference product Advil PM Liqui-Gels (ibuprofen/diphenhydramine hydrochloride 200 mg/25 mg) under fasting conditions.
Primary Outcome
Cmax was defined as maximum observed post-dose plasma concentration for ibuprofen obtained without interpolation. Blood samples were collected at indicated timepoints and pharmacokinetic (PK) analysis was performed. Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (CV%) is being reported.
Interventions
- DRUG Advil PM Liqui-Gels Minis
- DRUG Advil PM Liqui-Gels
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 77 participants |
| Start Date | 2023-01-05 |
| Est. Completion | 2023-03-21 |
| Phase | Phase 1 |
What the finished NCT05674721 record still lists
NCT05674721 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 77 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (28% higher).
The record links to 0 conditions, and to 2 interventions - of which Advil PM Liqui-Gels Minis is the first listed.
NCT05674721 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05674721 about?
NCT05674721 is a clinical study titled "A Bioequivalence Study of Advil PM Liqui-Gels Minis (Ibuprofen/Diphenhydramine Hydrochloride 200 mg/25 mg) Compared to the Current Marketed Advil PM Liqui-Gels (Ibuprofen/Diphenhydramine Hydrochloride 200 mg/25 mg) in Healthy Adult Subjects Under Fasted Conditions". The purpose of this study is to support the submission of Advil PM Liqui-Gels Minis (ibuprofen/diphenhydramine hydrochloride 200 milligrams \[mg\]/25 mg) which is a size reduction of the currently marketed Advil PM Liqui-Gels, by determining if this product is bioequivalent to the reference product ...
What is the current status of trial NCT05674721?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 77 participants. The study started on 2023-01-05. Estimated completion is 2023-03-21.
What interventions are being tested in trial NCT05674721?
The interventions under investigation include: Advil PM Liqui-Gels Minis (DRUG), Advil PM Liqui-Gels (DRUG).
Who is sponsoring clinical trial NCT05674721?
This trial is sponsored by HALEON, which has 34 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05674721's enrollment target sits among peer trials
77 703rd of 2000 higher than 1,296 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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