CompletedNCT00674310Updated Jan 23, 2018

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

An interventional study of Ropinirole Hydrochloride in Parkinson's Disease and Restless Leg Syndrome, sponsored by Roxane Laboratories. Completed. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-01-23.

Sponsored by Roxane Laboratories · Not applicable, Interventional, and Treatment

Phase: Not applicable
Study type: Interventional
Enrollment: 29
Allocation: Randomized
Ages: 18 Years to 45 Years
Sex: All

Study 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.

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Conditions studied

Parkinson's Disease
Restless Leg Syndrome

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In context

Parkinson Disease

4,487 studies on the registry are indexed under Parkinson Disease; 1,082 are open to participants now.

This study's enrollment of 29 is below the median of 40 across 3,294 interventional studies indexed under Parkinson Disease.

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Lead sponsor

Roxane Laboratories is the lead sponsor of 98 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 45 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

Inclusion criteria

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

Exclusion criteria

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.

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover assignment
Masking: None (open label)
Enrollment: 29 participants (actual)

Interventions

DrugRopinirole Hydrochloride
Restless Leg Syndrome

What researchers measure

Primary outcomes

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

Study locations

No study locations are listed for this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jan 23, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00674310
Lead sponsor: Roxane Laboratories
First posted: May 7, 2008
Start date: Feb 2004
Primary completion: Feb 2004
Completion: Feb 2004
Last update: Jan 23, 2018

Study contacts

Richard Larouche, M.D.

principal investigator · SFBC Anapharm

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.

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Discussion

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