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

Bioequivalence Between an Ibuprofen Suspension and a Reference Formulation. A Study in Healthy Volunteers.

This study is designed to assess bioequivalence between one test and one reference formulation used for temporary relief of pain. The results will help decide if the new medicine is likely to provide pain relief similar to the product being sold.

Study Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Drug: Ibuprofen; Drug: Ibuprofen

Detailed Description

The study is a single dose, randomized, two-way crossover study in 32 healthy male and female volunteers, minimum of 14 of each gender. Two doses of study medication will be given as single doses on two separate treatment visits. A washout of at least 48 hours will separate the treatment visits. Each visit will include an overnight fast at the clinic and 19 blood samples drawn for pharmacokinetic analyses. Tolerability of the treatments will be evaluated in terms of reported and observed adverse events (AE).

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Phase 1

Contacts and Locations

Study Locations

• Sweden
  • Lund, Sweden, 222 20
    • McNeil AB Clinical Pharmacology R&D

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Healthy (per protocol-specified parameters) male or female subjects (14 of each gender) between the ages of 18 and 50 years, inclusive.
• Non- or ex-tobacco user, being defined as someone who completely stopped smoking or using any form of tobacco for at least 12 months before screening visit of this study.
• For females: if not postmenopausal, agrees to use a protocol-specified means of contraception or declared absence of sexual contact with a male partner during the study.
• For males: No pregnant spouse or partner at screening and willingness to protect potential spouse or partner from becoming pregnant during the study.
• Body Mass Index (BMI) within protocol-specified parameters.
• A personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.
• Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures specified in the protocol.

Exclusion Criteria:

• Evidence or history of an acute or chronic medical or psychiatric condition, laboratory abnormality, or drug use that, in the judgment of the investigator or an authorized physician, may compromise subject safety or the interpretation of results.
• Females: Pregnant or breast-feeding
• Treatment with an investigational drug within 3 months preceding the first dose of study treatment.
• History of regular alcohol consumption outside the protocol-specified allowances.
• Donation or loss of blood within 3 months prior to the first treatment visit if the estimated lost blood volume equaled or exceeded 450 mL.
• Relationship to persons involved directly with the conduct of the study, or their families.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: A-IBU; A single 5 mL dose of 200 mg ibuprofen/5 mL experimental suspension, administered orally, with a 48-hour washout between visits.	Drug: Ibuprofen; A single 5 mL dose of 200 mg ibuprofen/5 mL experimental suspension, administered orally, with a 48-hour washout between visits; Other Names: Not yet marketed.; Drug: Ibuprofen; A single 5 mL dose of 200 mg ibuprofen/5 mL reference suspension, administered orally, with a 48-hour washout between visits; Other Names: Nurofen for Children Six Plus
ACTIVE_COMPARATOR: B-IBU; A single 5 mL dose of 200 mg ibuprofen/5 mL reference suspension, administered orally, with a 48-hour washout between visits	Drug: Ibuprofen; A single 5 mL dose of 200 mg ibuprofen/5 mL experimental suspension, administered orally, with a 48-hour washout between visits; Other Names: Not yet marketed.; Drug: Ibuprofen; A single 5 mL dose of 200 mg ibuprofen/5 mL reference suspension, administered orally, with a 48-hour washout between visits; Other Names: Nurofen for Children Six Plus

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cmax	Maximum observed plasma concentration (Cmax), is the maximum (peak) concentration (amount of drug) measured in blood plasma after a dose administration.	During 12 hours post-dose
AUCt	Area under the plasma concentration-vs.-time curve from start of drug administration until last measured concentration (AUCt), is a measure of how much of the drug reaches the bloodstream during the sampling period.	During 12 hours post-dose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUC∞	Area under the plasma concentration-vs.-time curve from start of drug administration and extrapolated to infinity (AUC∞), is a measure of how much of the drug ever reaches the bloodstream.	During 12 hours post-dose
tmax	The time at which maximum concentration is reached (tmax)	During 12 hours post-dose
Terminal Elimination Rate Constant (λz)	The terminal elimination rate constant (λz) describes the rate at which a drug is eliminated from the body.	During 12 hours post-dose
t½	Terminal half-life (t½) is the time required for the plasma concentration (as well as the amount of drug in the body) to fall by one-half.	During 12 hours post-dose
Mean Residence Time (MRT)	Mean residence time (MRT) is the mean time a drug molecule resides in the body.	During 12 hours post-dose

Collaborators and Investigators

• Sponsor: McNeil AB

Study record dates

Study Major Dates

• Study Start: February 1, 2012
• Primary Completion (ACTUAL): March 1, 2012
• Study Completion (ACTUAL): March 1, 2012

Study Registration Dates

• First Submitted: March 13, 2012
• First Submitted That Met QC Criteria: March 13, 2012
• First Posted (ESTIMATE): March 15, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): July 10, 2012
• Last Update Submitted That Met QC Criteria: July 6, 2012
• Last Verified: July 1, 2012

More Information

Terms related to this study

• Keywords: Pharmacokinetics
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Ibuprofen
• Other Study ID Numbers: IBUPAI1002; 2011-001570-26 (EUDRACT_NUMBER)