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Ibuprofen Suspension Bioequivalence Study | Clinical Trials | Clareo Health

COMPLETEDPHASE1

Ibuprofen Suspension Bioequivalence Study

A Randomized, Single-dose, 4-way Crossover, Open-label, Pharmacokinetic (PK) Study Comparing a 2% (w/v) Suspension of Ibuprofen (400 mg/20 mL Nurofen for Children®) With a Swiss Reference 2% (w/v) Suspension of Ibuprofen (400 mg/20 mL Algifor Dolo Junior®) in the Fed and Fasted States

NCT02503085•Reckitt Benckiser Healthcare (UK) Limited

View on ClinicalTrials.gov

Summary

The purpose of this study was to determine the rate and extent of absorption of Ibuprofen suspension formulations.

Eligibility

Age

18 - 50 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Subjects who have given written informed consent.
•Age: ≥18 years ≤50 years.
•Sex: Male or female subjects are eligible for entry.
•Female subject of child bearing potential with a negative pregnancy test at the screening visit and willing to use an effective method of contraception,
•Female subject of non-child bearing potential with negative pregnancy test at the screening visit
•Male subject willing to use an effective method of contraception, unless anatomically sterile
•Status: Healthy subjects as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory tests at screening.
•Healthy Subjects with a Body Mass Index (BMI) of ≥20 and ≤27 kg/m2

Exclusion Criteria

•Pregnancy or lactating female subjects.
•A history of significant disease of any body system.
•Any condition that may currently interfere with the absorption, distribution, metabolism or excretion of drugs.
•A history of allergy or intolerance related to treatment with ibuprofen, aspirin or other Non-Steroidal Anti-inflammatory Drug,or the excipients of the formulations.
•A history of or active peptic or duodenal ulcers or gastro-intestinal bleed or upper gastro-intestinal bleed, or other significant gastro-intestinal disorders.
•A history of frequent dyspepsia, e.g. heartburn or indigestion.
•A history of migraine.
•Current smokers and ex-smokers who have smoked within 6 months.
•A history of drug abuse (including alcohol).
•High consumption of stimulating drinks (caffeine intake per day above 300 mg).
+11 more criteria

Locations (1)

Reckit Benckiser

Hull, United Kingdom

Key Dates

Start Date

June 2, 2015

Primary Completion Date

August 25, 2015

Completion Date

August 25, 2015

Last Updated

April 13, 2018

Enrollment

ACTUAL participants

Conditions

Healthy Volunteer Study

Interventions

Nurofen for Children®

DRUG

Algifor Dolo Junior®

DRUG

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COMPLETEDPHASE1

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NCT06636500

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 13, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Ibuprofen Suspension Bioequivalence Study

Inclusion Criteria

Exclusion Criteria

Muscle Vibration as a Countermeasure Against Hypoactivity-induced

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