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 | Completed Phase 1

• 2 other identifiers: IBUPAI10022011-001570-26
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain

Keywords

Pharmacokinetics

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• AUC∞

  During 12 hours post-dose

• tmax

  During 12 hours post-dose

• Terminal Elimination Rate Constant (λz)

  During 12 hours post-dose

• t½

  During 12 hours post-dose

• Mean Residence Time (MRT)

  During 12 hours post-dose

Study Arms (2)

A-IBU

EXPERIMENTAL

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

Drug: Ibuprofen

B-IBU

ACTIVE COMPARATOR

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

Drug: Ibuprofen

Interventions

Ibuprofen DRUG

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

Also known as: Not yet marketed.

A-IBU

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• McNeil AB: lead

Study Sites (1)

McNeil AB Clinical Pharmacology R&D

Lund, 222 20, Sweden

Location

MeSH Terms

Conditions

Pain

Interventions

Ibuprofen

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Elisabeth Kruse, PhD

  McNeil AB

  STUDY DIRECTOR

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: March 13, 2012
• First Posted: March 15, 2012
• Study Start: February 1, 2012
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: July 10, 2012

Record last verified: 2012-07

Locations

SE (1)