Advil Mini for Bioequivalence

Overseen By Haleon Response Center

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: HALEON

Must be taking: Systemic contraceptives

Must not be taking: NSAIDs, Antihistamines

Disqualifiers: Asthma, Long QT syndrome, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 9 days

75 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this study is to assess the bioequivalence of Advil Tablet (Mini) (Test Product) to Advil Tablet (Reference Product) under fasted conditions and to characterize the impact of food on the bioavailability of the Test Product under fed conditions.

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

I am postmenopausal with an FSH level of 40 mIU/mL or higher.

I have had a hysterectomy and/or both ovaries removed.

I identify with my sex assigned at birth.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single oral dose of Advil (Mini) or Advil tablet under fasted or fed conditions in a crossover design

9 days

3 visits (in-person)

Washout

A washout period of at least 3 days between each treatment administration

6 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

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?

Group I: Sequence 6: Treatment C/ Treatment B/ Treatment A Experimental Treatment 2 Interventions

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.

Group II: Sequence 5: Treatment B/ Treatment A/ Treatment C Experimental Treatment 2 Interventions

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.

Group III: Sequence 4: Treatment A/ Treatment C/ Treatment B Experimental Treatment 2 Interventions

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.

Group IV: Sequence 3: Treatment C/ Treatment A/ Treatment B Experimental Treatment 2 Interventions

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.

Group V: Sequence 2: Treatment B/ Treatment C/ Treatment A Experimental Treatment 2 Interventions

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.

Group VI: Sequence 1: Treatment A/ Treatment B/ Treatment C Experimental Treatment 2 Interventions

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.

Who Is Running the Clinical Trial?

HALEON

Lead Sponsor

Trials

40

Recruited

6,000+