Ropinirole 0.25 mg Tablets Under Fasting Conditions

Teva Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Ropinirole HCl 0.25 mg Tablets; Drug: Requip® 0.25 mg Tablets

Study type: Interventional

Funder types: Industry

Identifiers

NCT00829504

10436008

Details and patient eligibility

About

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.

Full description

Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA bioequivalence statistical methods

Enrollment: 44 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

44 participants in 2 patient groups

1

Experimental group

Treatment:

Drug: Ropinirole HCl 0.25 mg Tablets

2

Active Comparator group

Treatment:

Drug: Requip® 0.25 mg Tablets