Advil Dual Action for Pain
Recruiting in Palo Alto (17 mi)
Age: 18 - 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1
Recruiting
Sponsor: HALEON
Must not be taking: Anticonvulsants, Herbal remedies
Disqualifiers: Pregnancy, Breastfeeding, Asthma, others
No Placebo Group
Trial Summary
What is the purpose of this trial?The primary purpose of this study is to demonstrate the bioequivalence of new formulation Advil Dual Action (ADA) liquid filled capsules (Test) compared to the currently marketed ADA Caplet (Reference) under fasted conditions and to assess the relative bioavailability of ADA liquid filled capsules (Test) under fed conditions compared to ADA liquid filled capsules (Reference) under fasted conditions.
Will I have to stop taking my current medications?
Yes, you will need to stop taking any medications, including over-the-counter drugs and herbal remedies, at least 2 weeks before the study starts, unless they are systemic contraceptives that you've been using consistently for at least 3 months.
What data supports the effectiveness of the drug Advil Dual Action Liquid Filled Capsules?
Research shows that ibuprofen, a component of Advil Dual Action, is effective in providing faster pain relief compared to some other pain medications, like celecoxib, especially in cases of dental pain. Additionally, liquid capsule formulations, like those used for diclofenac, are absorbed more quickly, which can lead to faster pain relief.
12345Is Advil Dual Action generally safe for humans?
Over-the-counter NSAIDs, like those in Advil Dual Action, have been associated with an increased risk of gastrointestinal bleeding, especially if not used as directed. It's important to follow usage instructions carefully to minimize potential risks.
16789How is Advil Dual Action different from other pain relief drugs?
Advil Dual Action Liquid Filled Capsules are unique because they combine two active ingredients, ibuprofen and acetaminophen, which work together to provide pain relief. This combination allows for effective pain management with potentially fewer side effects compared to using higher doses of a single ingredient.
1251011Eligibility Criteria
Healthy adults aged 18-55, with a BMI of 18.5 to 30 kg/m^2, can join this pain medication study if they agree to use contraception and follow the study plan. Excluded are those with certain health conditions, drug/alcohol abuse history, recent participation in other studies or blood donations.Inclusion Criteria
I am between 18 and 55 years old.
Participant must be willing and able to comply with scheduled visits, treatment plan, and study procedures
Participant must provide a signed and dated informed consent document before any assessment is performed
+3 more
Exclusion Criteria
Participant must not have certain laboratory abnormalities or vital sign deviations
Participant must not have positive urine drug/alcohol tests or specific consumption habits
Participant must not have participated in other studies involving investigational products within 30 days prior to study entry
+13 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
1-2 weeks
Treatment
Participants receive a single oral dose of investigational products in a four-treatment, four-period, four-sequence crossover design with a washout period of 3 days between treatments.
12 days
4 visits (in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Participant Groups
The trial is testing whether new ADA liquid capsules work the same as ADA caplets for pain relief when fasting and how well these capsules work after eating compared to taking them without food.
4Treatment groups
Experimental Treatment
Group I: Sequence 4: Treatment D + Treatment C + Treatment B + Treatment AExperimental Treatment3 Interventions
Participants will receive a single oral dose of 2 Advil Liqui-gels (ibuprofen 200 mg) under fasted conditions on Day 1 of Period 1 (Treatment D), followed by a single oral dose of 2 ADA liquid filled capsules (125 mg ibuprofen and 250 mg acetaminophen) under fed conditions, 30 minutes after a high-fat high calorie meal on Day 1 of Period 2 (Treatment C), followed by a single oral dose of 2 ADA Caplets (125 mg ibuprofen and 250 mg acetaminophen) under fasted conditions on Day 1 of Period 3 (Treatment B), and further followed by a single oral dose of 2 ADA liquid filled capsules (125 mg ibuprofen and 250 mg acetaminophen) under fasted conditions on Day 1 of Period 4 (Treatment A). There will be a washout period of at least 3 days between each treatment.
Group II: Sequence 3: Treatment C + Treatment A + Treatment D + Treatment BExperimental Treatment3 Interventions
Participants will receive a single oral dose of 2 ADA liquid filled capsules (125 mg ibuprofen and 250 mg acetaminophen) under fed conditions, 30 minutes after a high-fat high calorie meal on Day 1 of Period 1 (Treatment C), followed by a single oral dose of 2 ADA liquid filled capsules (125 mg ibuprofen and 250 mg acetaminophen) under fasted conditions on Day 1 of Period 2 (Treatment A), followed by a single oral dose of 2 Advil Liqui-gels (ibuprofen 200 mg) under fasted conditions on Day 1 of Period 3 (Treatment D) and further followed by a single oral dose of 2 ADA Caplets (125 mg ibuprofen and 250 mg acetaminophen) under fasted conditions on Day 1 of Period 4 (Treatment B). There will be a washout period of at least 3 days between each treatment.
Group III: Sequence 2: Treatment B + Treatment D + Treatment A + Treatment CExperimental Treatment3 Interventions
Participants will receive a single oral dose of 2 ADA Caplets (125 mg ibuprofen and 250 mg acetaminophen) under fasted conditions on Day 1 of Period 1 (Treatment B), followed by a single oral dose of 2 Advil Liqui-gels (ibuprofen 200 mg) under fasted conditions on Day 1 of Period 2 (Treatment D), followed by a single oral dose of 2 ADA liquid filled capsules (125 mg ibuprofen and 250 mg acetaminophen) under fasted conditions on Day 1 of Period 3 (Treatment A) and further followed by a single oral dose of ADA liquid filled capsules (125 mg ibuprofen and 250 mg acetaminophen) under fed conditions, 30 minutes after a high-fat high calorie meal on Day 1 of Period 4 (Treatment C). There will be a washout period of at least 3 days between each treatment.
Group IV: Sequence 1: Treatment A + Treatment B + Treatment C + Treatment DExperimental Treatment3 Interventions
Participants will receive a single oral dose of 2 ADA liquid filled capsules (125 mg ibuprofen and 250 mg acetaminophen) under fasted conditions on Day 1 of Period 1 (Treatment A), followed by a single oral dose of 2 ADA Caplets (125 mg ibuprofen and 250 mg acetaminophen) under fasted conditions on Day 1 of Period 2 (Treatment B), followed by a single oral dose of 2 ADA liquid filled capsules (125 mg ibuprofen and 250 mg acetaminophen) under fed conditions, 30 minutes after a high-fat high calorie meal on Day 1 of Period 3 (Treatment C) and further followed by a single oral dose of 2 Advil Liqui-gels (ibuprofen 200 mg) under fasted conditions on Day 1 of Period 4 (Treatment D). There will be a washout period of at least 3 days between each treatment.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Spaulding ClinicalWest Bend, WI
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Who Is Running the Clinical Trial?
HALEONLead Sponsor
References
Endoscopic evaluation of the gastro-duodenal tolerance of short-term analgesic treatment with 25 mg diclofenac-K liquid capsules. [2022]Diclofenac-potassium (diclofenac--K) 25 mg liquid capsule is absorbed more quickly than the tablet formulation. It offers potential for rapid pain relief, but may alter gastro-duodenal tolerability.
Diclofenac potassium 12.5 mg liquid capsules: earlier and higher exposure to diclofenac. A fasted, single-dose, comparative, bioavailability study versus diclofenac potassium 12.5 mg tablets. [2019]A fast-release liquid capsule formulation of low-dose diclofenac- K is available, which aims to improve patient convenience and compliance. The new formulation is a soft gelatin capsule designed to facilitate faster absorption of diclofenac versus the tablet form with anticipated overall comparable bioavailability.
Diclofenac potassium 25 mg liquid capsules: earlier and higher exposure to diclofenac. A fasted, single-dose, comparative bioavailability study vs. diclofenac potassium 2 x 12.5 mg tablets. [2019]A new liquid capsule formulation of low-dose diclofenac-K in 12.5 mg and 25 mg dosages has been developed to provide the patient with an easier to swallow form than the current low-dose tablets. The new formulation is expected to have a faster rate of absorption and comparable overall bioavailability compared with the tablet formulations.
Onset of analgesia and efficacy of ibuprofen sodium in postsurgical dental pain: a randomized, placebo-controlled study versus standard ibuprofen. [2022]A novel, immediate-release tablet formulation of ibuprofen (IBU) sodium dihydrate, Advil Film Coated Tablets (IBUNa), has been developed that is absorbed faster than standard IBU tablets. The objective of the current study was to compare the efficacy and onset of analgesia of this new formulation with standard IBU tablets after a single dose.
Efficacy and tolerability of nonprescription ibuprofen versus celecoxib for dental pain. [2019]Many clinicians appear confused about the purported clinical advantages of the new generation COX-2 inhibitors compared to both over-the-counter and prescription nonsteroidal anti-inflammatory analgesic agents (NSAIDs). Infact, there is a paucity of published information comparing the safety and efficacy of these two classes of drugs when used to treat acute pain. This study was designed to compare the safety and analgesic efficacy of an over-the-counter (OTC) analgesic, ibuprofen (Advil Liqui-Gels), to the leading prescription COX-2 inhibitor celecoxib (Celebrex). Ibuprofen liquigel is an encapsulated, solubilized potassium salt of ibuprofen that has a higher Cmax and shorter tmax than traditional ibuprofen solid-dosage formulations. This trial evaluated the maximum approved OTC dosing regimen (400 mg x 3, q4-6h) of ibuprofen liquigels compared to a single dose of celecoxib (200 mg) and placebo in 174 patients with moderate orsevere pain following surgical extraction of impacted third molars. The study design was multiple dose, randomized (stratified by baseline pain and gender), placebo controlled, double blind, double dummy, and parallel group. The onset of pain relief was determined using a two-stopwatch procedure. Treatments were also compared using standard indices of pain intensity and pain relief. The study demonstrated assay sensitivity in that both active medications were significantly more effective than placebo for all efficacy measures. In comparing the two active medications, the time to meaningful relief was significantly shorter, and the mean 4-, 8-, and 12-hour summed pain relief combined with pain intensity difference scores were significantly higher for ibuprofen liquigels compared with celecoxib (p
What do Australian & New Zealand caregivers know about children's ibuprofen? The results of an online survey? [2019]Children's formulations containing ibuprofen are frequently used to treat pain and fever. These medications, available over-the-counter, have the potential to cause adverse events if usage/safety information is not adhered to. This study aimed to investigate caregivers' knowledge about the safe use of a commonly purchased children's formulation containing ibuprofen.
Potential for Detection of Safety Signals for Over-the-Counter Medicines Using National ADR Spontaneous Reporting Data: The Example of OTC NSAID-Associated Gastrointestinal Bleeding. [2020]One post-marketing surveillance challenge for many regulatory authorities is access to information regarding the safety of over-the-counter (OTC) medicines. National spontaneous adverse drug reaction (ADR) report data represent a rich potential data source for the detection of safety signals associated with OTC medicines, yet little is known regarding the possibility of detecting safety signals for OTC medicines within these datasets. The aim of this study was to evaluate the potential for detecting safety signals for OTC medicines in National ADR spontaneous reporting data, using OTC non-steroidal anti-inflammatory drugs (NSAIDs) and gastrointestinal bleeding as an example. Data from the Australian Adverse Drug Reactions System (ADRS) dataset (1971-2008) and the Canadian Vigilance Adverse Reaction Online Database (VAROD) (1965-2013) were used to explore the feasibility of using spontaneous reporting data, exploring the association between gastrointestinal bleeding and the use of OTC NSAIDs. Safety signals were examined using disproportionality analyses and reporting odds ratios calculated. After adjusting for age, gender, medications known to increase the risk of bleeding, and medications used for the management of conditions associated with an increased risk of bleeding, a two-fold increase in the risk of gastrointestinal (GI) bleeding with OTC NSAID was observed within each dataset. This study demonstrates that spontaneous ADR reporting data can be used in pharmacovigilance to monitor the safety of OTC medicines.
Treatment Satisfaction, Efficacy, and Tolerability of Low-Dose Diclofenac Epolamine Soft Capsules in Acute, Mild, or Moderate Musculoskeletal Pain: A Prospective Open-Label, Single-Arm Interventional Study. [2023]The use of oral nonsteroidal anti-inflammatory drugs (NSAIDs) for acute musculoskeletal pain should be at the lowest effective dosage and for the shortest duration to minimize potential adverse effects. This study evaluated treatment satisfaction, effectiveness, and tolerability of a low-dose diclofenac epolamine 12.5-mg soft capsule formulation (DHEP 12.5-mg capsules) using patient-reported outcome measures in a real-life setting over a short period (3 days) in subjects with mild-to-moderate acute musculoskeletal pain.
The efficacy and safety of paracetamol for pain relief: an overview of systematic reviews. [2021]To evaluate the efficacy and safety of paracetamol as an analgesic medication in a range of painful conditions.
Effects of food intake on the pharmacokinetics of diclofenac potassium soft gelatin capsules: a single-dose, randomized, two-way crossover study. [2013]Diclofenac potassium liquid-filled soft gelatin capsule (DPSGC) is an investigational formulation that uses dispersing agents designed to facilitate rapid and consistent absorption of this NSAID.
Analgesic efficacy of liquid ketoprofen compared to liquid dipyrone and placebo administered orally as drops in postepisiotomy pain. [2015]The objective of this single-center, single-dose, double-blind randomized parallel group study was to evaluate the analgesic efficacy of a new liquid formulation of ketoprofen at two dose levels (25 mg or 50 mg) compared to a commercially available liquid form of dipyrone 500 mg and placebo with all treatments administered as drops to patients with severe postepisiotomy pain.