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

Roxane Laboratories29 enrolled

Overview

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 fed conditions using a single dose, randomized, 2-treatment, 2-period, 2-sequence cross-over design.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Parkinson's Disease Restless Leg Syndrome

Interventions

Ropinirole HydrochlorideDRUG

Restless Leg Syndrome

Eligibility

Sex: ALLMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * No clinically significant abnormal finding on the physical examination, medical history, or clinical laboratory results during screening 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.

Outcomes

Primary Outcomes

Bioequivalence

Time frame: Baseline, Two period, seven day washout

Data from ClinicalTrials.gov

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