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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 is a Phase 1 study that has completed, run by HALEON. The registered enrollment target is 77 participants.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05674721
The ClinicalTrials.gov registry entry for NCT05674721 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 77 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is HALEON, which has 34 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Advil PM Liqui-Gels Minis is the first listed.
NCT05674721 reports 0 study locations.
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.
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