Ropinirole 0.25 mg Tablets Under Fasting Conditions
This study has been completed.
Sponsor:
Teva Pharmaceuticals USA
Information provided by:
Teva Pharmaceuticals USA
ClinicalTrials.gov Identifier:
NCT00829504
First received: January 26, 2009
Last updated: September 1, 2009
Last verified: September 2009
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Healthy |
Drug: Ropinirole HCl 0.25 mg Tablets Drug: Requip® 0.25 mg Tablets |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Bio-equivalence Study Intervention Model: Crossover Assignment Masking: Open Label |
| Official Title: | The Relative Bioavailability Study of Two Ropinirole 0.25 mg Tablets Under Fasting Conditions. |
Resource links provided by NLM:
Further study details as provided by Teva Pharmaceuticals USA:
Primary Outcome Measures:
- Cmax (Maximum Observed Concentration of Drug Substance in Plasma) [ Time Frame: Blood samples collected over a 24 hour period. ] [ Designated as safety issue: No ]
- AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration) [ Time Frame: Blood samples collected over a 24 hour period. ] [ Designated as safety issue: No ]
- AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity) [ Time Frame: Blood samples collected over a 24 hour period. ] [ Designated as safety issue: No ]
| Enrollment: | 44 |
| Study Start Date: | October 2004 |
| Study Completion Date: | October 2004 |
| Primary Completion Date: | October 2004 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Drug: Ropinirole HCl 0.25 mg Tablets
1 x 0.25 mg
|
| Active Comparator: 2 |
Drug: Requip® 0.25 mg Tablets
1 x 0.25 mg
|
Detailed Description:
Criteria for Evaluation: FDA Bioequivalence Criteria
Statistical Methods: FDA bioequivalence statistical methods
Eligibility| Ages Eligible for Study: | 18 Years to 45 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00829504
Locations
| United States, Texas | |
| Novum Pharmaceutical Research Services | |
| Houston, Texas, United States, 77042 | |
Sponsors and Collaborators
Teva Pharmaceuticals USA
Investigators
| Principal Investigator: | Soran Hong, M.D. | Novum Pharmaceuticals Research Services |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00829504 History of Changes |
| Other Study ID Numbers: | 10436008 |
| Study First Received: | January 26, 2009 |
| Results First Received: | July 6, 2009 |
| Last Updated: | September 1, 2009 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Teva Pharmaceuticals USA:
|
Bioequivalence Healthy Subjects |
Additional relevant MeSH terms:
|
Ropinirole Antiparkinson Agents Anti-Dyskinesia Agents Central Nervous System Agents Therapeutic Uses Pharmacologic Actions |
Dopamine Agonists Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 23, 2013