Advil Mini for Bioequivalence
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a mini version of Advil (ibuprofen) to determine if it works the same way in the body as regular Advil. Researchers aim to understand how this mini Advil behaves when taken on an empty stomach versus after eating. Ideal participants are healthy individuals without allergies to pain relievers like Advil or aspirin and who have not recently experienced asthma or significant allergies. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants a chance to contribute to the foundational understanding of this medication.
Will I have to stop taking my current medications?
Yes, you will need to stop taking most medications, including over-the-counter and herbal remedies, at least 2 weeks before the study starts. However, you can continue using systemic contraceptives, hormone replacement therapy, and occasional acetaminophen.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that the new Advil Mini is safe for use. In one study, participants reported no serious side effects with this version. They also found it easy to swallow, which is a nice bonus. The study confirmed that Advil Mini works as effectively as regular Advil tablets. Although this study is in the early stages of clinical trials, the absence of serious side effects is a positive sign for its safety.12345
Why are researchers excited about this trial's treatments?
Researchers are excited about Advil Mini because it offers a more convenient and potentially faster-acting option for pain relief. Unlike traditional ibuprofen tablets, this smaller version can be easier to swallow, which is a big plus for many people. Moreover, the study is examining how taking it with or without food affects its effectiveness, which could lead to more tailored and effective pain management strategies. Overall, Advil Mini might provide the same reliable relief as standard ibuprofen but with added flexibility and ease of use.
What evidence suggests that this trial's treatments could be effective?
This trial will compare the bioequivalence of Advil Mini tablets to regular Advil tablets. Research has shown that the new Advil Mini tablets are designed to provide the same pain relief as regular Advil tablets. Studies indicate that smaller versions like Advil Mini are just as effective as larger ones. The main benefit of the Mini version is its smaller size, which may make it easier to swallow for some people. Overall, the pain relief and effectiveness are expected to match those of regular Advil tablets.12345
Are You a Good Fit for This Trial?
Healthy adults, male or female, aged 18-55 with a BMI of 18.5-30 kg/m^2 and weight over 50 kg for males and over 45 kg for females can join. Postmenopausal women or those who've had certain surgeries may also participate if they meet other health criteria.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a single oral dose of Advil (Mini) or Advil tablet under fasted or fed conditions in a crossover design
Washout
A washout period of at least 3 days between each treatment administration
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Ibuprofen
Trial Overview
The study is testing whether the new Advil Tablet (Mini) works the same as the regular Advil Tablet when taken without food, and how food affects its absorption into the body.
How Is the Trial Designed?
6
Treatment groups
Experimental Treatment
Participants will receive a single oral dose of Advil (Mini) under fed conditions on Day 1 of Period 1 (Treatment C), followed by a single oral dose of Advil tablet under fasted conditions on Day 1 of Period 2 (Treatment B), followed by a single oral dose of Advil (Mini) tablet under fasted conditions on Day 1 of Period 3 (Treatment A). There will be a washout period of at least 3 days between each treatment.
Participants will receive a single oral dose of Advil tablet under fasted conditions on Day 1 of Period 1 (Treatment B), followed by a single oral dose of Advil (Mini) tablet under fasted conditions on Day 1 of Period 2 (Treatment A), followed by a single oral dose of Advil (Mini) under fed conditions on Day 1 of Period 3 (Treatment C). There will be a washout period of at least 3 days between each treatment.
Participants will receive a single oral dose of Advil (Mini) tablet under fasted conditions on Day 1 of Period 1 (Treatment A), followed by a single oral dose of Advil (Mini) under fed conditions, on Day 1 of Period 2 (Treatment C), followed by a single oral dose of Advil tablet under fasted conditions on Day 1 of Period 3 (Treatment B). There will be a washout period of at least 3 days between each treatment.
Participants will receive a single oral dose of Advil (Mini) under fed conditions, on Day 1 of Period 1 (Treatment C), followed by a single oral dose of Advil (Mini) tablet under fasted conditions on Day 1 of Period 2 (Treatment A), followed by a single oral dose of Advil tablet under fasted conditions on Day 1 of Period 3 (Treatment B). There will be a washout period of at least 3 days between each treatment.
Participants will receive a single oral dose of Advil tablet under fasted conditions on Day 1 of Period 1 (Treatment B), followed by a single oral dose of Advil (Mini) under fed conditions, on Day 1 of Period 2 (Treatment C), followed by a single oral dose of Advil (Mini) tablet under fasted conditions on Day 1 of Period 3 (Treatment A). There will be a washout period of at least 3 days between each treatment.
Participants will receive a single oral dose of Advil (Mini) tablet under fasted conditions on Day 1 of Period 1 (Treatment A), followed by a single oral dose of Advil tablet under fasted conditions on Day 1 of Period 2 (Treatment B), followed by a single oral dose of Advil (Mini) under fed conditions, on Day 1 of Period 3 (Treatment C). 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
Citations
A Bioequivalence Study of Advil Tablet (Mini) (Ibuprofen ...
The purpose of this study is to assess the bioequivalence of Advil Tablet (Mini) (Test Product) to Advil Tablet (Reference Product) under ...
Bioequivalence Study of Ibuprofen and Diphenhydramine ...
This study aimed to establish the bioequivalence of Advil PM Liqui-Gels Minis (ibuprofen/diphenhydramine hydrochloride 200 mg/25 mg) which is a size reduction ...
Advil Mini for Bioequivalence
The purpose of this study is to assess the bioequivalence of Advil Tablet (Mini) (Test Product) to Advil Tablet (Reference Product) under ...
Bioequivalence Study of Ibuprofen and Diphenhydramine ...
Conclusion: The new Advil PM Liqui-Gels Minis formulation is bioequivalent to the marketed Advil PM Liqui-Gels. The smaller capsule size may offer a more ...
Bioequivalence Study of Ibuprofen and Diphenhydramine ...
Conclusion The new Advil PM Liqui-Gels Minis formulation is bioequivalent to the marketed Advil PM Liqui-Gels. The smaller capsule size may ...
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