MedTrace Logo

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 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2012-07-10

No results posted yet for this study

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

Interventions

DRUG

Ibuprofen

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 reference suspension, administered orally, with a 48-hour washout between visits

Sponsors & Collaborators

  • McNeil AB

    lead INDUSTRY

Principal Investigators

  • Elisabeth Kruse, PhD · McNeil AB

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-02-29
Primary Completion
2012-03-31
Completion
2012-03-31

Countries

  • Sweden

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01555476 on ClinicalTrials.gov