Ropinirole 0.25 mg Tablets Under Fasting Conditions

• Status: Completed
• Trial end date: 2004-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Teva Pharmaceuticals USA
• Treatments: Ropinirole

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.