A Bioequivalence Study of Advil Tablet (Mini) (Ibuprofen 200 mg) Versus Advil Tablet (Ibuprofen 200 mg) in Healthy Adult Subjects Under Fasted Conditions and Bioavailability Assessment of Advil Tablet (Mini) Under Fed Conditions
NCT07345130 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 50
Last updated 2026-03-13
Summary
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.
Conditions
- Bioequivalence
- Bioavailability
Interventions
- DRUG
-
Advil Tablet (Mini) (Test Product)
200 mg Ibuprofen
- DRUG
-
Advil Tablet (Reference Product)
200 mg Ibuprofen
Sponsors & Collaborators
-
HALEON
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- OTHER
- Masking
- NONE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Max Age
- 55 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2025-12-17
- Primary Completion
- 2026-02-03
- Completion
- 2026-02-03
- FDA Drug
- Yes
Countries
- United States
Study Locations
More Related Trials
-
Bioequivalence Study Between Two Oral Formulations of Ibuprofen 800 mg Tablets Under Fed Conditions
NCT00803946 ·Status: COMPLETED ·Phase: PHASE1
-
Bioequivalence Study of Ibuprofen 200 mg/5 mL Oral Suspension vs. MOMENT 200 mg Coated Tablet
NCT02902289 ·Status: COMPLETED ·Phase: PHASE1
-
Bioequivalence of a Fixed Dose Combination Tablet Containing 200 mg Ibuprofen and 30 mg Pseudoephedrine-HCl Compared to RhinAdvil(R)(200 mg Ibuprofen and 30 mg Pseudoephedrine-HCl) as a Fixed Dose Combination Tablet Administered in Healthy Volunteers.
NCT01170637 ·Status: COMPLETED ·Phase: PHASE1
-
Bioequivalency Study of Ibuprofen 200 mg and Pseudoephedrine HCL 30 mg Tablets of Dr. Reddy's Under Fasting Conditions
NCT01131780 ·Status: COMPLETED ·Phase: PHASE1
-
Bioequivalence Study of Ibuprofen 200 mg Soft Gel Capsules of Dr. Reddy's Laboratories Limited Under Fed Conditions
NCT01149954 ·Status: COMPLETED ·Phase: PHASE1
-
Bioequivalence Study of Ibuprofen 400 mg/10 mL Oral Suspension vs. MOMENTACT 400 mg Film-coated Tablet
NCT02902302 ·Status: COMPLETED ·Phase: PHASE1
-
Study to Investigate the Relative Bioavailability of Ibuprofen in Healthy Volunteers
NCT02183012 ·Status: COMPLETED ·Phase: PHASE1
-
Ibuprofen Bioavailability Trial With Oral Single Dose Administration.
NCT03018015 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Test Bioequivalence Between One Test Formulation of Ibuprofen and Two Reference Treatments
NCT01316978 ·Status: COMPLETED ·Phase: PHASE1
-
A Study Comparing Three Formulations of Ibuprofen in Healthy Subjects
NCT02256423 ·Status: COMPLETED ·Phase: PHASE1
-
Study Comparing the Efficacy of Two Ibuprofen Formulations
NCT00740857 ·Status: COMPLETED ·Phase: PHASE4
-
To Evaluate the Food Effect and the Absorption Profile of Ibuprofen Controlled-Release Tablets 600 mg in Comparison to the Reference Standard Ibuprofen Tablets in Normal Healthy Volunteers
NCT03418805 ·Status: TERMINATED ·Phase: PHASE1
-
Bioequivalence Study of Ibuprofen 200 mg + Pseudoephedrine HCL 30 mg Tablets Under Fed Conditions
NCT01132222 ·Status: COMPLETED ·Phase: PHASE1
-
Pharmacokinetic Study Of Ibuprofen Injection (IVIb) In Healthy Adult Subjects
NCT00867880 ·Status: COMPLETED ·Phase: PHASE1
-
A Comparative Bioavailability Study of Reformulated Ibuprofen 2% and 4% Oral Suspensions (Berlin Chemie AG) and Versus Ibuprofen (Nurofen®) 200 mg/5 ml Oral Suspension
NCT07036861 ·Status: COMPLETED ·Phase: PHASE1
-
Study to Test the Blood to See if a New Medicine is Likely to Provide Pain Relief Similar to a Product Already Sold in Stores
NCT01555476 ·Status: COMPLETED ·Phase: PHASE1
-
Actual Use and Compliance Study Of Ibuprofen 600 Mg Immediate Release/Extended Release Tablets In At-Risk OTC Consumers
NCT03722238 ·Status: TERMINATED ·Phase: PHASE3
-
Single-Dose Bioavailability Study of Two Formulations of Ibuprofen and Pseudoephedrine Hydrochloride Tablets
NCT03429738 ·Status: COMPLETED ·Phase: PHASE1
-
Bioequivalence Study of Ibuprofen D, Oral Suspension, 200 mg/5ml and Nurofen®, Oral Suspension 100 mg/5 ml in Healthy Volunteers Under Fasting Conditions
NCT03561558 ·Status: COMPLETED ·Phase: PHASE1
-
A Bioequivalence Study Of Ibuprofen 50mg/ml (laboratórios Pfizer Ltda) In The Oral Suspension Form.
NCT01350596 ·Status: COMPLETED ·Phase: PHASE4
-
A Bioequivalence Study of Two Ibuprofen Arginine Granules 400 mg Formulations Under Fasting and Fed Conditions in Chinese Healthy Adult Subjects
NCT05737069 ·Status: COMPLETED ·Phase: PHASE1
-
Pharmacokinetics of 3 Formulations of Ibuprofen Suppositories
NCT00921830 ·Status: COMPLETED ·Phase: PHASE1
-
Bioequivalence Study of Test and Reference 400 mg Ibuprofen Coated Tablets in Healthy Volunteers
NCT05663398 ·Status: COMPLETED ·Phase: PHASE1
-
Bioequivalence Study of Dr.Reddy's Ibuprofen and Diphenhydramine Citrate 200 mg/38 mg Caplets Under Fasting Condition
NCT01053208 ·Status: COMPLETED ·Phase: PHASE1
-
Tolerability and Efficacy of Ibuprofen 800 mg in a Walking Model of Osteoarthritis Pain (0000-057)
NCT00565084 ·Status: COMPLETED ·Phase: PHASE1