Phase 1
Completed N=44
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
Source: ClinicalTrials.gov NCT05674721 ↗Enrolled (actual)
44
Serious AEs
0.0%
Results posted
Aug 2024
Primary outcomePrimary: Maximum Observed Plasma Concentration (Cmax) for Ibuprofen — 36879.50; 38875.03 nanogram per milliliter (ng/mL)
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Observed Plasma Concentration (Cmax) for Ibuprofen |
36879.50; 38875.03 | — |
| PRIMARY Cmax for Diphenhydramine |
75.40; 73.22 | — |
| PRIMARY Area Under the Plasma Concentration Versus Time Curve Calculated From Time 0 to the Last Measurable Sampling Time Point (t) (AUC [0-t]) for Ibuprofen |
121612.36; 123012.43 | — |
| PRIMARY AUC (0-t) for Diphenhydramine |
746.76; 728.13 | — |
| PRIMARY Area Under the Plasma Concentration Versus Time Curve Calculated From Time 0 to Infinity (AUC [0-inf]) for Ibuprofen |
123067.92; 124401.36 | — |
| PRIMARY AUC (0-inf) for Diphenhydramine |
782.89; 762.79 | — |
| SECONDARY Terminal Elimination Rate Constant (λz) for Ibuprofen |
0.3252; 0.3329 | — |
| SECONDARY λz for Diphenhydramine |
0.0665; 0.0669 | — |
| SECONDARY Time of the Maximum Observed Post-dose Concentration (Tmax) for Ibuprofen |
1.000; 0.875 | — |
| SECONDARY Tmax for Diphenhydramine |
3.000; 3.000 | — |
| SECONDARY The Elimination Half-life (t1/2) for Ibuprofen |
2.21; 2.04 | — |
| SECONDARY t1/2 for Diphenhydramine |
10.71; 10.45 | — |
| SECONDARY Apparent Volume of Distribution (Vz/F) for Ibuprofen |
10.35; 10.17 | — |
| SECONDARY Vz/F for Diphenhydramine |
1059.73; 1071.75 | — |
| SECONDARY Apparent Total Clearance (CI/F) for Ibuprofen |
3.33; 3.28 | — |
| SECONDARY CI/F for Diphenhydramine |
71.95; 72.85 | — |
| SECONDARY Number of Participants Reporting Ease of Swallowing on 5-Point Ordinal Scale |
0; 0; 0; 0; 0; 1 | — |
Eligibility Criteria
Inclusion Criteria
- Evidence of a personally signed and dated informed consent document indicating that the participant has been informed of all pertinent aspects of the study before any assessment is performed.
- Participant who is willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
- Healthy participant, which is defined as in general good physical health, as judged by the investigator and no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead Electrocardiogram (ECG) or clinical laboratory tests.
- Body Mass Index (BMI) of 18.5 to 30.0 Kilogram per meter square (kg/m^2); and a total body weight greater than or equal to (>=)50.0 Kilogram (kg) for males and >=45.0 kg for females.
- Female participant of childbearing potential and at risk for pregnancy must agree to use a highly effective method of contraception throughout the study and for at least 30 days after the last dose of assigned treatment. Female participant who is not of childbearing potential must meet at least one of the following criteria: A. Achieved postmenopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; and have a serum follicle-stimulating hormone (FSH) level >= 40 mili international unit per milliliter (mIU/mL) B. Have undergone a documented (including self-reported) hysterectomy and/or bilateral oophorectomy.
- Participant with two negative tests (one at screening within 72 hours of admission and one at check in Day-1 in Period 1) for active coronavirus disease 2019 (COVID-19), separated by more than (>)24 hours.
Exclusion Criteria
- Participant who is an investigational site staff member directly involved in the conduct of the study and his/her family members, site staff member otherwise supervised by the Investigator, or participant who is a GlaxoSmithKline (GSK) employee directly involved in the conduct of the study.
- Participation in other studies involving investigational drug(s) within 30 days prior to study entry and/or during study participation.
- Acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study.
- Pregnant female participant as confirmed by a positive pregnancy test or intending to become pregnant over the duration of the study.
- Breastfeeding female participant.
- Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients (gelatin, medium-chain triglycerides, pharmaceutical ink, polyethylene glycol, potassium hydroxide, purified water, sorbitol sorbitan solution).
- Any history of asthma, urticaria, or other significant allergic diathesis or allergic reaction to any other pain reliever/fever reducer. Participant with uncomplicated seasonal allergic rhinitis can be accepted if expected allergy season is clearly outside enrollment/treatment period.
- Diagnosis of long QT syndrome or QTcF > 450 millisecond (msec) for males and > 470 msec for females at screening.
- Clinically significant vital sign abnormalities (systolic blood pressure lower than 90 or over 140 millimeters of mercury [mmHg], diastolic blood pressure lower than 50 or over 90 mmHg, or pulse rate less than 50 or over 100 beats per minute [bpm]).
- Unwilling or unable to comply with the Lifestyle Considerations described in this protocol.
- Use of any medication (including over the counter [OTC] medications and herbal remedies) within 2 weeks or within less than 10 times the elimination half-life of the respective drug (whichever is
Data sourced from ClinicalTrials.gov (NCT05674721). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.