Bioequivalence Study of Ibuprofen 200 mg Soft Gel Capsules of Dr. Reddy's Laboratories Limited Under Fed Conditions

NCT01149954 | Completed Phase 1 DMC

• 1 other identifier: 02280
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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 fed conditions.

Conditions

Healthy

Keywords

Bioequivalence; Crossover; Ibuprofen

Outcome Measures

Primary Outcomes (1)

• Bioequivalence based on Cmax and AUC parameters

  1 month

Study Arms (2)

Ibuprofen

EXPERIMENTAL

Ibuprofen 200 mg gel Capsules of Dr. Reddy's laboratories Limited

Drug: Ibuprofen

Advil

ACTIVE COMPARATOR

Advil liquigels 200 mg gel capsules of Wyeth Consumer Healthcare

Drug: Ibuprofen

Interventions

Ibuprofen DRUG

Ibuprofen 200 mg gel capsules of Dr. Reddy's Laboratories Limited

Also known as: Advil liquigels 200 mg gel capsules

Advil; Ibuprofen

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Subjects will be females and/or males, smokers and/or non-smokers, 18 years of age and older.

You may not qualify if:

• Clinically significant illnesses within 4 weeks of the administration of study medication.
• Clinically significant surgery within 4 weeks prior to the administration of the study medication.
• Any clinically significant abnormality found during medical screening.
• Any reason which, in the opinion of the medical subinvestigator, would prevent the subject from participating in the study.
• Abnormal laboratory tests judged clinically significant.
• Positive urine drug screen at screening.
• Positive testing for hepatitis B, hepatitis C or at screening.
• ECG abnormalities (clinically significant) or vital sign abnormalities (systolic blood pressure lower than 90 or over 140 mmHg, or diastolic blood pressure lower than 50 or over 90 mmHg; or heart rate less than 50 or over 100 bpm) at screening.
• Subjects with Body Mass Index (BMI) ≥30.0.
• History of significant alcohol abuse within six months of the screening visit or any indication of the regular use of more than fourteen units of alcohol per week (1 unit = 150 mL of wine or 360 mL of beer or 45 mL of alcohol 40%).
• History of drug abuse or use of illegal drugs: use of soft drugs (such as marijuana) within 3 months of the screening visit or hard drugs (such as cocaine, phencyclidine (PCP) and crack) within 1 year of the screening visit.
• History of allergic reactions to ibuprofen or other NSAIDs (e.g. aspirin, diclofenac,diflunisal, etodolac, ketoprofen, fenoprofen, floctafenine, flurbiprofen, indomethacin,ketorolac, mefenamic acid, nabumetone, naproxen, oxaprozin, piroxicam, salsalate,sulindac, tenoxicam, tiaprofenic acid and tolmetin).
• History of allergic reactions to heparin.
• Use of any drugs known to induce or inhibit hepatic drug metabolism (examples of inducers: barbiturates, carbamazepine, phenytoin, glucocorticoids, rifampin/rifabutin;examples of inhibitors: antidepressants, cimetidine, diltiazem, erythromycin,ketoconazole, Mono Amine Oxadise (MAO) inhibitors, neuroleptics, verapamil, quinidine) within 30 days prior to administration of the study medication.
• Use of an investigational drug or participation in an investigational study within 30 days prior to administration of the study medication.

Sponsors & Collaborators

• Dr. Reddy's Laboratories Limited: lead

Study Sites (1)

Anaphann Inc.

Québec, GIV 2K8, Canada

Location

MeSH Terms

Interventions

Ibuprofen; Gels

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Benoit Girard, MD

  Anapharm

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 23, 2010
• First Posted: June 24, 2010
• Study Start: January 1, 2003
• Primary Completion: January 1, 2003
• Study Completion: January 1, 2003
• Last Updated: June 29, 2010

Record last verified: 2010-06

Locations

CA (1)