Bioequivalence Study of Ibuprofen 200 mg Gel Capsules of Dr. Reddy's Laboratories Under Fasting Condition
Summary
The purpose of this study is to compare the rate and extent of absorption of ibuprofen 200 mg gelcaps (test) versus Advil liquigels (reference) administered as 1 x 200 mg gelcap under fasting conditions.
Description
Randomized, 2-way crossover, bioequivalence study of Ibuprofen 200 mg gel capsules and Advil liquigels 200 mg gel caps administered as 1 x 200 mg gel capsule in healthy subjects under fasting conditions.
Study Design
Allocation: Randomized, Control: Active Control, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Conditions
Healthy
Intervention
Ibuprofen
Location
Anaphann Inc.
Quebec
Canada
GIV 2K8
Status
Completed
Source
Dr. Reddy's Laboratories Limited
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT01149941
- Information obtained from ClinicalTrials.gov on July 15, 2010
Published on BioPortfolio: 2014-08-27T03:12:42-0400
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Medical and Biotech [MESH] Definitions
Healthy People Programs
Healthy People Programs are a set of health objectives to be used by governments, communities, professional organizations, and others to help develop programs to improve health. It builds on initiatives pursued over the past two decades beginning with the 1979 Surgeon General's Report, Healthy People, Healthy People 2000: National Health Promotion and Disease Prevention Objectives, and Healthy People 2010. These established national health objectives and served as the basis for the development of state and community plans. These are administered by the Office of Disease Prevention and Health Promotion (ODPHP). Similar programs are conducted by other national governments.
Ibuprofen
A nonsteroidal anti-inflammatory agent with analgesic properties used in the therapy of rheumatism and arthritis.
Ketoprofen
An IBUPROFEN-type anti-inflammatory analgesic and antipyretic. It is used in the treatment of rheumatoid arthritis and osteoarthritis.
Nutrition Policy
Governmental guidelines and objectives pertaining to public food supply and nutrition including recommendations for healthy diet and changes in food habits to ensure healthy diet.
Suprofen
An IBUPROFEN-type anti-inflammatory analgesic and antipyretic. It inhibits prostaglandin synthesis and has been proposed as an anti-arthritic.
