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

Sponsored by:	Roxane Laboratories
Information provided by:	Roxane Laboratories
ClinicalTrials.gov Identifier:	NCT00674310

Purpose

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	Intervention
Parkinson's Disease Restless Leg Syndrome	Drug: Ropinirole Hydrochloride

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Crossover Assignment, Bio-equivalence Study
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 Parkinson disease

MedlinePlus related topics: 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:

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)

Intervention Details:

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

Study placed in the following topic categories:

Neurotransmitter Agents
Ropinirole
Ganglion Cysts
Basal Ganglia Diseases
Dyssomnias
Central Nervous System Diseases
Sleep Disorders
Psychomotor Agitation
Dopamine Agonists
Brain Diseases

Neurodegenerative Diseases
Sleep Disorders, Intrinsic
Dopamine
Malnutrition
Mental Disorders
Parkinson Disease
Movement Disorders
Restless Legs Syndrome
Dopamine Agents
Parkinsonian Disorders

Additional relevant MeSH terms:

Neurotransmitter Agents
Ropinirole
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Physiological Effects of Drugs
Basal Ganglia Diseases
Sleep Disorders
Antiparkinson Agents
Neurodegenerative Diseases
Brain Diseases
Dopamine Agonists
Sleep Disorders, Intrinsic
Pathologic Processes
Movement Disorders

Mental Disorders
Syndrome
Therapeutic Uses
Restless Legs Syndrome
Disease
Nervous System Diseases
Parasomnias
Dyssomnias
Central Nervous System Diseases
Pharmacologic Actions
Parkinson Disease
Dopamine Agents
Parkinsonian Disorders
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 10, 2009