Ropinirole 0.25 mg Tablets Under Fasting Conditions

NCT ID: NCT00829504

Last Updated: 2009-09-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-10-31
• Study Completion Date: 2004-10-31

Brief 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.

Detailed Description

Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA bioequivalence statistical methods

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Blinding Strategy: NONE

Study Groups

1

Group Type: EXPERIMENTAL

Ropinirole HCl 0.25 mg Tablets

Intervention Type: DRUG

1 x 0.25 mg

2

Group Type: ACTIVE_COMPARATOR

Requip® 0.25 mg Tablets

Intervention Type: DRUG

1 x 0.25 mg

Interventions

Ropinirole HCl 0.25 mg Tablets

1 x 0.25 mg

Intervention Type: DRUG

Requip® 0.25 mg Tablets

1 x 0.25 mg

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Teva Pharmaceuticals USA

INDUSTRY

Sponsor Role: lead

Principal Investigators

Soran Hong, M.D.

Role: PRINCIPAL_INVESTIGATOR

Novum Pharmaceuticals Research Services

Locations

Novum Pharmaceutical Research Services

Houston, Texas, United States

Countries

United States

Other Identifiers

10436008

Identifier Type: -

Identifier Source: org_study_id