Ropinirole 0.25 mg Tablets Under Fasting Conditions

Completed · Phase 1

Conditions studied: Healthy

In brief

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.

Key facts

Study ID

NCT00829504

Run by

Teva Pharmaceuticals USA

People needed

44

Starts

2004-10-01

Expected to finish

2004-10-01

Last updated by the study team

2009-09-11

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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

You may not qualify if…

• 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.

Where it is running

• Novum Pharmaceutical Research Services — Houston, Texas, United States

Full record on ClinicalTrials.gov

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