Bioequivalence Study Between Two Oral Formulations of Ibuprofen 800 mg Tablets Under Fasting Conditions

NCT ID: NCT00804440

Last Updated: 2012-03-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-01-31

Brief Summary

Compare the rate and extent of absorption of two oral formulations of Ibuprofen 800 mg Tablets, administered as a single, one-tablet dose in fasted subjects.

Conditions

Bioequivalency

Study Design

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

Study Groups

Test Product

Group Type: ACTIVE_COMPARATOR

Ibuprofen Tablets, 800 mg

Intervention Type: DRUG

Reference Product

Group Type: ACTIVE_COMPARATOR

Ibuprofen Tablets, 800 mg

Intervention Type: DRUG

Interventions

Ibuprofen Tablets, 800 mg

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• healthy men or women, 18 years of age or older
• body mass index between 19 and 30
• willing to participate and sign a copy of the informed consent form

Exclusion Criteria

• history of allergy or hypersensitivity to ibuprofen
• recent history of drug or alcohol addiction or abuse
• pregnant or lactating women
• use of tobacco products within 3 months prior to study dosing
• evidence of a clinically significant disorder or whose laboratory results were deemed to be clinically significant
• receipt of any drugs as part of a research study within 30 days prior to study dosing

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

Sponsors

Perrigo Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

30470

Identifier Type: -

Identifier Source: org_study_id