Status:
COMPLETED
Ropinirole 0.25 mg Tablets Under Fasting Conditions
Lead Sponsor:
Teva Pharmaceuticals USA
Conditions:
Healthy
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
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 Smi...
Detailed Description
Criteria for Evaluation: FDA Bioequivalence Criteria Statistical Methods: FDA bioequivalence statistical methods
Eligibility Criteria
Inclusion
- Healthy (physical exam, laboratory tests, medical history and ECG), non-smoker males and/or females who were between 18 and 45 years old
Exclusion
- 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.
Key Trial Info
Start Date :
October 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2004
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT00829504
Start Date
October 1 2004
End Date
October 1 2004
Last Update
September 11 2009
Active Locations (1)
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1
Novum Pharmaceutical Research Services
Houston, Texas, United States, 77042