Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Teva Pharmaceuticals USA
Criteria for Evaluation: FDA Bioequivalence Criteria
Statistical Methods: FDA bioequivalence statistical methods
Age
18–45
Sex
ALL
Healthy volunteers
Accepted
You may be eligible 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 be 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.
