A Single Dose, 2-Period, 2-Treatment, 2-Way Crossover Bioequivalency Study of Ropinirole 0.25 mg Tablets Und Fasted Conditions

Not Applicable

Completed

• Conditions: Parkinson's Disease; Restless Leg Syndrome

• Registration Number: NCT00673088
• Lead Sponsor: Roxane Laboratories

Brief Summary

The objective of this study was to assess the single dose bioequivalence of Roxane's Ropinirole Tablets, 0.25 mg to ReQuip Tablets, 0.25 mg (GlaxoSmithKline) under fasting conditions using a single-dose, randomized, 2-treatment, 2-period, 2-sequence cross-over design.

Detailed Description

The objective of this study was to assess the single dose bioequivalence of Roxane's Ropinirole Tablets, 0.25 mg to ReQuip Tablets, 0.25 mg (GlaxoSmithKline) under fasting conditions using a single-dose, randomized, 2-treatment, 2-period, 2-sequence cross-over design.

Study Timeline

• Study Start: 2004-02
• Primary Completion: 2004-02
• Study Completion: 2004-02
• Study First Submitted: 2008-05-05
• Study First Submitted QC: 2008-05-06
• Study First Posted: 2008-05-07
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-19
• Last Update Posted: 2018-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening.

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Exclusion Criteria

• Positive test for HIV, Hepatitis B, or Hepatitis C.
• Treatment with known enzyme altering drugs.
• History of allergic or adverse response to ropinirole or any other comparable product.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Bioequivalence	Baseline, Two Period, seven day washout