Ropinirole 0.25 mg Tablets Under Fasting Conditions

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Requip® 0.25 mg Tablets; Drug: Ropinirole HCl 0.25 mg Tablets

• Registration Number: NCT00829504
• Lead Sponsor: Teva Pharmaceuticals USA

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 SmithKline Beecham Pharmaceuticals for GlaxoSmithKline) under fasting conditions in healthy, non-smoking, adult subjects.

Detailed Description

Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA bioequivalence statistical methods

Study Timeline

• Study Start: 2004-10
• Primary Completion: 2004-10
• Study Completion: 2004-10
• Study First Submitted: 2009-01-26
• Study First Submitted QC: 2009-01-26
• Study First Posted: 2009-01-27
• Results First Submitted: 2009-07-06
• Results First Submitted QC: 2009-07-06
• Results First Posted: 2009-08-18
• Status Verified: 2009-09
• Last Update Submitted: 2009-09-01
• Last Update Posted: 2009-09-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
2	Requip® 0.25 mg Tablets	-
1	Ropinirole HCl 0.25 mg Tablets	-

Primary Outcome Measures

Name	Time	Method
AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)	Blood samples collected over a 24 hour period.	Bioequivalence based on AUC0-inf.
Cmax (Maximum Observed Concentration of Drug Substance in Plasma)	Blood samples collected over a 24 hour period.	Bioequivalence based on Cmax.
AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)	Blood samples collected over a 24 hour period.	Bioequivalence based on AUC0-t.

Trial Locations

Locations (1)

Novum Pharmaceutical Research Services; 🇺🇸 Houston, Texas, United States