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

Bioequivalency Clinical Trial

Official title:

A Randomized, Single-Dose, Two-Way Crossover Relative Bioavailability Study of Ibuprofen Tablet Formulations in Fasted Normal, Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00804440
• Other study ID #: 30470
• Status: Completed
• Phase: Phase 1
• First received: December 5, 2008
• Last updated: March 15, 2012
• Start date: January 2004

Study information

• Verified date: March 2012
• Source: Perrigo Company
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. primary completion date: January 2004
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bioequivalency

Intervention

Drug:
• Ibuprofen Tablets, 800 mg

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Perrigo Company

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bioequivalence was assessed on the pharmacokinetic variables Cmax, AUC,0-t, and AUC,0-infinity			No