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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:
Information provided by:
Roxane Laboratories
ClinicalTrials.gov Identifier:
NCT00673088
First received: May 5, 2008
Last updated: May 21, 2008
Last verified: May 2008
History of Changes
  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
Endpoint Classification: Bio-equivalence 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 Und Fasted Conditions

Resource links provided by NLM:

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: 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

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 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00673088

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., SFBC Anapharm
ClinicalTrials.gov Identifier: NCT00673088     History of Changes
Other Study ID Numbers: ROPI-T25-PVFS-1
Study First Received: May 5, 2008
Last Updated: May 21, 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 May 19, 2013