Ibuprofen Suspension Bioequivalence Study

NCT02503085 | Completed Phase 1 Results

• 2 other identifiers: NL13042013-003366-14
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Volunteer Study

Keywords

Ibuprofen

Outcome Measures

Primary Outcomes (2)

• Maximum Plasma Concentration (Cmax)

  Pre-dose, 10, 15, 20, 30, 40, 50, 60, 70, 80, 90, 105, 120, 180, 240, 360, 480, 720 and 1440 mins (Day 1, Post-dose)

• Area Under the Plasma Concentration-time Curve From Administration to the Last Quantifiable Concentration at Time t (AUC0-t)

  Pre-dose, 10, 15, 20, 30, 40, 50, 60, 70, 80, 90, 105, 120, 180, 240, 360, 480, 720 and 1440 mins (Day 1, Post-dose)

Secondary Outcomes (7)

• Elimination Rate Constant (Kel)

  Pre-dose, 10, 15, 20, 30, 40, 50, 60, 70, 80, 90, 105, 120, 180, 240, 360, 480, 720 and 1440 mins (Day 1, Post-dose)

• AUC From Administration to Infinity (AUC0-inf)

  Pre-dose, 10, 15, 20, 30, 40, 50, 60, 70, 80, 90, 105, 120, 180, 240, 360, 480, 720 and 1440 mins (Day 1, Post-dose)

• Ratio of AUC0-t/AUC0-inf (AUCR)

  Pre-dose, 10, 15, 20, 30, 40, 50, 60, 70, 80, 90, 105, 120, 180, 240, 360, 480, 720 and 1440 mins (Day 1, Post-dose)

• Time to Cmax (Tmax)

  Pre-dose, 10, 15, 20, 30, 40, 50, 60, 70, 80, 90, 105, 120, 180, 240, 360, 480, 720 and 1440 mins (Day 1, Post-dose)

• Plasma Concentration Half-life (T1/2)

  Pre-dose, 10, 15, 20, 30, 40, 50, 60, 70, 80, 90, 105, 120, 180, 240, 360, 480, 720 and 1440 mins (Day 1, Post-dose)

Study Arms (4)

Nurofen for Children® (fasted)

EXPERIMENTAL

Nurofen for Children® suspension 400 mg/20 mL single-oral dose under fasted condition

Drug: Nurofen for Children®

Nurofen for Children® (fed)

EXPERIMENTAL

Nurofen for Children® suspension 400 mg/20 mL single-oral dose under fed condition

Drug: Nurofen for Children®

Algifor Dolo Junior® (fasted)

ACTIVE COMPARATOR

Algifor Dolo Junior® suspension 400 mg/20 mL single-oral dose under fasted condition

Drug: Algifor Dolo Junior®

Algifor Dolo Junior® (fed)

ACTIVE COMPARATOR

Algifor Dolo Junior® suspension 400 mg/20 mL single-oral dose under fed condition

Drug: Algifor Dolo Junior®

Interventions

Nurofen for Children® DRUG

Also known as: Ibuprofen orange oral suspension

Nurofen for Children® (fasted); Nurofen for Children® (fed)

Algifor Dolo Junior® DRUG

Also known as: Ibuprofen oral suspension

Algifor Dolo Junior® (fasted); Algifor Dolo Junior® (fed)

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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).
• Those with positive drugs of abuse screen including alcohol on any occasion throughout the study.
• Ingestion of a prescribed drug at any time in the 14 days before dosing with study medication (excluding hormonal contraceptives and hormone replacement therapy), or consumption of enzyme inhibitors or inducers during the previous month (such as barbiturates, carbamazepine, erythromycin, phenytoin, etc.).
• Ingestion of an over-the-counter preparation within 7 days before dosing with study medication.
• Donation of blood in quantity in the previous 12 weeks before enrolment into the study.
• Known human immune deficiency virus (HIV) positive status, or a positive viral serology screen.

Sponsors & Collaborators

• Reckitt Benckiser Healthcare (UK) Limited: lead

Study Sites (1)

Reckit Benckiser

Hull, United Kingdom

Location

Results Point of Contact

• Title: Clinical Research Director
• Organization: Reckitt Benckiser Healthcare (UK) Ltd.

+441482 326151

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2015
• First Posted: July 20, 2015
• Study Start: June 2, 2015
• Primary Completion: August 25, 2015
• Study Completion: August 25, 2015
• Last Updated: April 13, 2018
• Results First Posted: April 13, 2018

Record last verified: 2018-04

Locations

GB (1)