Phase 1
Completed N=44
Ropinirole 0.25 mg Tablets Under Fasting Conditions
Healthy
Source: ClinicalTrials.gov NCT00829504 ↗
Enrolled (actual)
44
Serious AEs
—
Results posted
Aug 2009
Primary outcomePrimary: Cmax (Maximum Observed Concentration of Drug Substance in Plasma) — 552.1; 546.5 pg/mL
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cmax (Maximum Observed Concentration of Drug Substance in Plasma) |
552.1; 546.5 | — |
| PRIMARY AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration) |
4190.92; 4062.99 | — |
| PRIMARY AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity) |
4469; 4305.88 | — |
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.
Data sourced from ClinicalTrials.gov (NCT00829504). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.