54 Participants Needed

Advil Dual Action for Pain

HR
Overseen ByHaleon Response Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

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.12345

Is 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.16789

How 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.1251011

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.

Eligibility 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

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
I am in good physical and mental health with no major health issues.
See 2 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
See 13 more

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

Treatment Details

Interventions

  • Advil Dual Action Liquid Filled Capsules
Trial Overview 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.
Participant Groups
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

Who Is Running the Clinical Trial?

HALEON

Lead Sponsor

Trials
40
Recruited
6,000+

Findings from Research

In a study involving 132 volunteers, diclofenac-potassium 25 mg liquid capsules showed a lower incidence of erosive gastro-duodenal lesions (53%) compared to acetylsalicylic acid (94%) and had better tolerability than ibuprofen (75%).
The liquid formulation also inhibited gastric mucosal prostaglandin synthesis by 52%, which is comparable to diclofenac tablets (64%) and ibuprofen (50%), indicating that it may provide effective pain relief with a similar safety profile.
Endoscopic evaluation of the gastro-duodenal tolerance of short-term analgesic treatment with 25 mg diclofenac-K liquid capsules.Hawkey, C., Burnett, I., Gold, MS., et al.[2022]
The study involving 42 healthy subjects showed that the new liquid capsule formulation of diclofenac-K provides faster absorption compared to the traditional tablet form, with a median time to peak concentration (tmax) of about 10 minutes faster.
Both formulations had equivalent overall systemic exposure, but the liquid capsules resulted in nearly double the peak concentration (Cmax), suggesting they may offer a quicker pain relief effect without any safety concerns.
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.Kienzler, JL., Gold, M.[2019]
The new 25 mg liquid capsule formulation of diclofenac-K provides a faster absorption rate compared to the traditional 2 × 12.5 mg tablets, with nearly double the peak concentration (Cmax) of diclofenac in the bloodstream.
Both the liquid capsule and tablet formulations showed equivalent overall systemic exposure to diclofenac, and both were well tolerated by participants, with only one minor drug-related adverse event reported.
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.Armogida, M., Gold, M.[2019]

References

Endoscopic evaluation of the gastro-duodenal tolerance of short-term analgesic treatment with 25 mg diclofenac-K liquid capsules. [2022]
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]
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]
Onset of analgesia and efficacy of ibuprofen sodium in postsurgical dental pain: a randomized, placebo-controlled study versus standard ibuprofen. [2022]
Efficacy and tolerability of nonprescription ibuprofen versus celecoxib for dental pain. [2019]
What do Australian & New Zealand caregivers know about children's ibuprofen? The results of an online survey? [2019]
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]
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 efficacy and safety of paracetamol for pain relief: an overview of systematic reviews. [2021]
10.United Statespubmed.ncbi.nlm.nih.gov
Effects of food intake on the pharmacokinetics of diclofenac potassium soft gelatin capsules: a single-dose, randomized, two-way crossover study. [2013]
Analgesic efficacy of liquid ketoprofen compared to liquid dipyrone and placebo administered orally as drops in postepisiotomy pain. [2015]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security