The Relative Bioavailability Study of Two Ropinirole 0.25 mg Tablets Under Fed Conditions
Condition: Healthy
MeSH terms: Malnutrition
Intervention: Ropinirole HCl 0.25 mg Tablets; Requip® 0.25 mg Tablets
Intervention description: 1 x 0.25 mg, single dose fed; 1 x 0.25 mg, single dose fed
Intervention MeSH terms: Ropinirole
Phase: Phase 1
Study type: Interventional
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 46.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Bioequivalence; Healthy Subjects

Summary:

      The purpose of this study is to compare relative bioavailability of the test formulation of
      ropinirole hydrochloride 0.25 mg tablets (Manufactured and distributed by TEVA
      Pharmaceuticals USA) with the already approved formulation REQUIP® (ropinirole hydrochloride)
      0.25 mg tablets (GlaxoSmithKline) under fed conditions in healthy, adult subjects.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males and females, 18 to 45 years of age (inclusive), with a body mass index (BMI) of
             19-30 kg/m² inclusive and weighing at least 120 lbs.

          -  Sitting (at least 5 minutes) blood pressure of at least 100/70 and sitting pulse of at
             least 60 b.p.m.

          -  Good health as determined by lack of clinically significant abnormalities in health
             assessments performed at screening.

          -  Signed and dated informed consent form, which meets all criteria of current FDA
             regulations.

          -  If female and of child bearing potential, subjects must be prepared to abstain from
             sexual intercourse or use a reliable barrier method of contraception (e.g. condom with
             spermicide, IUD) during the duration of the study. Female subjects who have used oral
             contraceptives within 14 days or injected or implanted hormonal contraceptives within
             180 days of dosing will not be allowed to participate.

        Exclusion Criteria:

          -  If female, pregnant, lactating, or likely to become pregnant during the 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 or 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, arrhythmia, tachycardia, seizure
             disorder or glaucoma.

          -  Presence of gastrointestinal disease or history of malabsorption within the last year.

          -  History of psychiatric disorders occurring 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 14 days prior to dosing.

          -  Positive test results for HIC, Hepatitis B surface antigen or Hepatitis C antibody.

          -  Positive test results for drugs of abuse at screening.

          -  Positive serum pregnancy test.

          -  Tobacco user within 90 days of the first study dose.

          -  Unable, or unwilling to tolerate multiple venipunctures.

          -  Difficulty fasting or eating the standard meals that will be provided.