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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00673088
First Posted: May 7, 2008
Last Update Posted: May 22, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Roxane Laboratories
  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 fasting 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: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (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 Und Fasted Conditions

Resource links provided by NLM:


Further study details as provided by Roxane Laboratories:

Primary Outcome Measures:
  • Bioequivalence [ Time Frame: Baseline, Two Period, seven day washout ]

Enrollment: 30
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:
    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 fasting conditions using a single-dose, randomized, 2-treatment, 2-period, 2-sequence cross-over design.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • No clinically significant abnormal findings 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00673088


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

Responsible Party: Richard Larouche, M.D., SFBC Anapharm
ClinicalTrials.gov Identifier: NCT00673088     History of Changes
Other Study ID Numbers: ROPI-T25-PVFS-1
First Submitted: May 5, 2008
First Posted: May 7, 2008
Last Update Posted: May 22, 2008
Last Verified: May 2008

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 Wake Disorders
Parasomnias
Mental Disorders
Ropinirole
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs