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Nonsteroidal Anti-inflammatory Drug (NSAID)

Advil PM Liqui-Gels Minis for Pain

Phase 1
Waitlist Available
Research Sponsored by HALEON
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one hour prior to dosing (pre-dose) and at 10, 15, 30, 45 minutes and 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.25, 3.5, 3.75, 4, 4.25, 4.5, 4.75, 5, 5.25, 5.5, 6, 8, 10, 12, 16, 24, 36, and 48 hours following dosing
Awards & highlights

Study Summary

This trial tests if a smaller size version of Advil PM is just as effective as the original.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one hour prior to dosing (pre-dose) and at 10, 15, 30, 45 minutes and 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.25, 3.5, 3.75, 4, 4.25, 4.5, 4.75, 5, 5.25, 5.5, 6, 8, 10, 12 and 16 hours following dosing
This trial's timeline: 3 weeks for screening, Varies for treatment, and one hour prior to dosing (pre-dose) and at 10, 15, 30, 45 minutes and 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.25, 3.5, 3.75, 4, 4.25, 4.5, 4.75, 5, 5.25, 5.5, 6, 8, 10, 12 and 16 hours following dosing for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
AUC (0-t) for Diphenhydramine
AUC [0-inf]) for Diphenhydramine
Area Under the Plasma Concentration Versus Time Curve Calculated from Time 0 to infinity (AUC [0-inf]) for ibuprofen
+3 more
Secondary outcome measures
Apparent Total Clearance (CI/F) for Ibuprofen
Apparent Volume of Distribution (Vz/F) for Ibuprofen
CI/F for Diphenhydramine
+8 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Advil PM Liqui-Gels MinisExperimental Treatment1 Intervention
Participants will be randomly assigned as per cross-over design to receive a single dose of 2 Advil PM Liqui-Gels Minis capsules orally on day 1 of period 1 and will receive single dose of 2 Advil PM Liqui-Gels capsules orally on day 1 of period 2 with at least 7 days washout period. Participants will be instructed to consume the entire amount of ambient temperature water (approximately 240 milliliters [mL]) along their investigational product.
Group II: Advil PM Liqui-GelsActive Control1 Intervention
Participants will be randomly assigned as per cross-over design to receive a single dose of 2 Advil PM Liqui-Gels capsules orally on day 1 of period 1 and will receive single dose of 2 Advil PM Liqui-Gels Minis capsules orally on day 1 of period 2 with at least 7 days washout period. Participants will be instructed to consume the entire amount of ambient temperature water (approximately 240 mL) along their investigational product.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Advil PM Liqui-Gels Minis
2023
Completed Phase 1
~50

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

HALEONLead Sponsor
27 Previous Clinical Trials
3,692 Total Patients Enrolled
2 Trials studying Pain
145 Patients Enrolled for Pain

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment for this endeavor currently underway?

"Affirmative. The clinicaltrials.gov listing reveals that, as of February 8th 2023, this investigation is still seeking individuals to join the trial which was first advertised on May 1st 2023. A total of 44 patients need to be recruited from one medical facility."

Answered by AI

Is Advil PM Liqui-Gels Minis a secure treatment option for individuals?

"Based on our evaluation, Advil PM Liqui-Gels Minis is assessed with a score of 1 due to its current Phase 1 status and lack of robust clinical data demonstrating safety or effectiveness."

Answered by AI

What is the primary ambition of this trial?

"According to the study sponsor, HALEON, this trial aims to measure Maximum Observed Plasma Concentration (Cmax) for Ibuprofen across a One hour pre-dose and post-dosing time span. Additionally, Apparent Total Clearance (CI/F), Ease of Swallowing on a 5-Point Ordinal Scale and Time of Maximum Plasma Concentrations (Tmax) will be monitored as secondary objectives."

Answered by AI

Are elderly individuals being considered for participation in this scientific experiment?

"According to the outlined criteria, individuals aged 18 and above yet below 55 are qualified for this clinical trial."

Answered by AI

What criteria must an individual fulfill to qualify for this research study?

"The prerequisites for this trial include being aged 18 to 55 and experiencing some degree of pain. A maximum of 44 individuals that satisfy these criteria can join the medical research project."

Answered by AI

What is the current enrollment figure of participants in this study?

"Affirmative. Records hosted on clinicaltrials.gov verify that this medical trial, which was first launched on May 1st 2023, is actively recruiting patients. 44 individuals must be recruited from a single location for the experiment to continue."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
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
2023. "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". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05674721.
~20 spots leftby Apr 2025
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