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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00674310

Enrollment

Registered

2008-05-07

Start date

2004-02-29

Completion date

2004-02-29

Last updated

2018-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson's Disease, Restless Leg Syndrome

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

Detailed description

Interventions

DRUGRopinirole Hydrochloride

Restless Leg Syndrome

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 45 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
Bioequivalence	Baseline, Two period, seven day washout

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026