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Ropinirole 0.25 mg Tablets Under Fasting Conditions
This study has been completed.
First Received: January 26, 2009   Last Updated: July 6, 2009   History of Changes
Sponsored by: Teva Pharmaceuticals USA
Information provided by: Teva Pharmaceuticals USA
ClinicalTrials.gov Identifier: NCT00829504
  Purpose

The objective of this study was to compare the relative bioavailability of the test formulation of Ropinirole (TEVA Pharmaceuticals USA) with already marketed reference of Requip® (Manufactured by SmithKline Beecham Pharmaceuticals for GlaxoSmithKline) under fasting conditions in healthy, non-smoking, adult subjects.


Condition Intervention Phase
Healthy
Drug: Ropinirole HCl 0.25 mg Tablets
Drug: Requip® 0.25 mg Tablets
Phase I

Study Type: Interventional
Study Design: Randomized, Open Label, Crossover Assignment, Bio-equivalence Study
Official Title: The Relative Bioavailability Study of Two Ropinirole 0.25 mg Tablets Under Fasting Conditions.

Resource links provided by NLM:


Further study details as provided by Teva Pharmaceuticals USA:

Primary Outcome Measures:
  • Cmax (Maximum Observed Concentration) [ Time Frame: Blood samples collected over a 24 hour period. ] [ Designated as safety issue: No ]
  • AUC0-t (Area Under the Concentration-Time Curve From Time Zero to Time of Last Measurable Concentration) [ Time Frame: Blood samples collected over a 24 hour period. ] [ Designated as safety issue: No ]
  • AUC0-Inf (Area Under the Concentration-Time Curve From Time Zero to Infinity) [ Time Frame: Blood samples collected over a 24 hour period. ] [ Designated as safety issue: No ]

Enrollment: 44
Study Start Date: October 2004
Study Completion Date: October 2004
Primary Completion Date: October 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental Drug: Ropinirole HCl 0.25 mg Tablets
1 x 0.25 mg
2: Active Comparator Drug: Requip® 0.25 mg Tablets
1 x 0.25 mg

Detailed Description:

Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA bioequivalence statistical methods

  Eligibility

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

Inclusion Criteria:

  • Healthy (physical exam, laboratory tests, medical history and ECG), non-smoker males and/or females who were between 18 and 45 years old

Exclusion Criteria:

  • If female, pregnant, lactating or likely to become pregnant during this study.
  • History of allergy or sensitivity to ropinirole or other dopamine agonists (e.g. Corolpam®, Dostinex®, Mirapex®, Permax®, Symmetrel®) or history of any drug hypersensitivity of intolerance which, in the opinion of the Investigator, would compromise the safety of the subject or the study.
  • History of dizziness, lightheadedness or fainting upon standing.
  • Significant history or current evidence of chronic infectious disease, system disorders, organ dysfunction, hyper/hypotension, arrythmia, tachycardia, seizure disorder or glaucoma.
  • Presence of gastrointestinal disease or history of malabsorption within the last year.
  • History of psychiatric disorders occuring within the last two years that required hospitalization or medication.
  • Presence of a medical condition requiring regular treatment with prescription drugs.
  • Use of pharmacologic agents known to significantly induce or inhibit drug-metabolizing enzymes within 30 days prior to dosing.
  • Receipt of any drug as part of a research study within 30 days prior to dosing.
  • Drug or alcohol addiction requiring treatment in the past 12 months.
  • Donation or significant loss of whole blood (480 ml or more) within 30 days or plasma within the past 14 days prior to dosing.
  • Positive test results for HIV, Hepatitis B surface antigen or Hepatitis C antibody.
  • Positive test results for drugs of abuse at screening.
  • Tobacco user within 90 days of the first study date.
  • Unable, or unwilling to tolerate multiple venipunctures.
  • Difficulty fasting or eating the standard meals that will be provided.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00829504

Locations
United States, Texas
Novum Pharmaceutical Research Services
Houston, Texas, United States, 77042
Sponsors and Collaborators
Teva Pharmaceuticals USA
Investigators
Principal Investigator: Soran Hong, M.D. Novum Pharmaceuticals Research Services
  More Information

No publications provided

Study ID Numbers: 10436008
Study First Received: January 26, 2009
Results First Received: July 6, 2009
Last Updated: July 6, 2009
ClinicalTrials.gov Identifier: NCT00829504     History of Changes
Health Authority: United States: Institutional Review Board

Keywords provided by Teva Pharmaceuticals USA:
Bioequivalence
Healthy Subjects

Study placed in the following topic categories:
Neurotransmitter Agents
Ropinirole
Dopamine
Dopamine Agents
Healthy
Dopamine Agonists

Additional relevant MeSH terms:
Neurotransmitter Agents
Ropinirole
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Therapeutic Uses
Physiological Effects of Drugs
Antiparkinson Agents
Dopamine Agents
Dopamine Agonists
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 10, 2009