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Ropinirole 0.25 mg Tablets Under Fasting Conditions

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00829504
First Posted: January 27, 2009
Last Update Posted: September 11, 2009
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:
Teva Pharmaceuticals USA
  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 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
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 of Drug Substance in Plasma) [ Time Frame: Blood samples collected over a 24 hour period. ]
  • 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. ]
  • AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity) [ Time Frame: Blood samples collected over a 24 hour period. ]

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
Experimental: 1 Drug: Ropinirole HCl 0.25 mg Tablets
1 x 0.25 mg
Active Comparator: 2 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

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:

  • 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
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): 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

ClinicalTrials.gov Identifier: NCT00829504     History of Changes
Other Study ID Numbers: 10436008
First Submitted: January 26, 2009
First Posted: January 27, 2009
Results First Submitted: July 6, 2009
Results First Posted: August 18, 2009
Last Update Posted: September 11, 2009
Last Verified: September 2009

Keywords provided by Teva Pharmaceuticals USA:
Bioequivalence
Healthy Subjects

Additional relevant MeSH terms:
Ropinirole
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs