A Single-Dose, 2-Period, 2-Treatment, 2-Way Crossover Bioequivalency Study of Ropinirole 0.25 mg Tablets Under Fed Conditions

This study has been completed.

First Received on May 5, 2008.  
Last Updated on May 20, 2008  
History of Changes
This Clinical Trial Sponsored By: Roxane Laboratories
Information provided by: Roxane Laboratories
ClinicalTrials.gov Identifier: NCT00674310
 

Purpose for Clinical Trial

The objective of this study was to assess the single dose bioequivalence of Roxane’s Ropinirole tablets,0.25 mg, to ReQuip Tablets, 0.25 mg (GlaxoSmithKline) under fed conditions using a single dose, randomized, 2-treatment, 2-period, 2-sequence cross-over design.

Condition Study Intervention
Parkinson’s Disease
Restless Leg Syndrome
Drug: Ropinirole Hydrochloride

Study Type: Study Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Study Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Single-Dose, 2-Period, 2-Treatment, 2-Way Crossover Bioequivalency Study of Ropinirole 0.25 mg Tablets Under Fed Conditions

Resource links provided by NLM:

Genetics Home Reference related topics:
familial paroxysmal nonkinesigenic dyskinesia
Perry syndrome
MedlinePlus related topics:
Malnutrition
Parkinson’s Disease
Restless Legs
Drug Information available for:
Ropinirole hydrochloride
Ropinirole

U.S. FDA Resources

Further study details as provided by Roxane Laboratories:

Primary Outcome Measures For Clinical Trial:

  • Bioequivalence [ Time Frame: Baseline, Two period, seven day washout ] [ Designated as safety issue: No ]

Enrollment: 29
Study Start Date: February 2004
Study Completion Date: February 2004
Primary Completion Date: February 2004 (Final data collection date for primary outcome measure)
Study Intervention Details:

    Drug: Ropinirole Hydrochloride

    Restless Leg Syndrome

Detailed Description:

The objective of this study was to assess the single dose bioequivalence of Roxane’s Ropinirole tablets,0.25 mg, to ReQuip Tablets, 0.25 mg (GlaxoSmithKline) under fed conditions using a single dose, randomized, 2-treatment, 2-period, 2-sequence cross-over design.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • No clinically significant abnormal finding on the physical examination, medical history, or clinical laboratory results during screening

Exclusion Criteria:

  • Positive test for HIV, Hepatitis B, or Hepatitis C.
  • Treatment with known enzyme altering drugs.
  • History of allergic or adverse response to ropinirole or any other comparable product.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00674310

Sponsors and Collaborators
Roxane Laboratories
Investigators
Principal Investigator: Richard Larouche, M.D. SFBC Anapharm
  More Information

No publications provided

Responsible Party: Richard Larouche, M.D., SFB C Anapharm
ClinicalTrials.gov Identifier: NCT00674310    
History of Changes
Other Study ID Numbers: ROPI-T25-PVFD-1
Study First Received: May 5, 2008
Last Updated: May 20, 2008
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:

Parkinson Disease
Restless Legs Syndrome
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Parasomnias
Mental Disorders
Ropinirole
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 21, 2012

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