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

NCT ID: NCT01555476

Last Updated: 2012-07-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-02-29
• Study Completion Date: 2012-03-31

Brief Summary

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.

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).

Conditions

Pain

Keywords

Pharmacokinetics

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

A-IBU

A single 5 mL dose of 200 mg ibuprofen/5 mL experimental suspension, administered orally, with a 48-hour washout between visits.

Group Type: EXPERIMENTAL

Ibuprofen

Intervention Type: DRUG

A single 5 mL dose of 200 mg ibuprofen/5 mL experimental suspension, administered orally, with a 48-hour washout between visits

B-IBU

A single 5 mL dose of 200 mg ibuprofen/5 mL reference suspension, administered orally, with a 48-hour washout between visits

Group Type: ACTIVE_COMPARATOR

Ibuprofen

Intervention Type: DRUG

A single 5 mL dose of 200 mg ibuprofen/5 mL reference suspension, administered orally, with a 48-hour washout between visits

Interventions

Ibuprofen

A single 5 mL dose of 200 mg ibuprofen/5 mL experimental suspension, administered orally, with a 48-hour washout between visits

Intervention Type: DRUG

Ibuprofen

A single 5 mL dose of 200 mg ibuprofen/5 mL reference suspension, administered orally, with a 48-hour washout between visits

Intervention Type: DRUG

Other Intervention Names

Not yet marketed.; Nurofen for Children Six Plus

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

McNeil AB

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Elisabeth Kruse, PhD

Role: STUDY_DIRECTOR

McNeil AB

Locations

McNeil AB Clinical Pharmacology R&D

Lund, , Sweden

Countries

Sweden

Other Identifiers

2011-001570-26

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

IBUPAI1002

Identifier Type: -

Identifier Source: org_study_id