A Single-Dose, 2-Period, 2-Treatment, 2-Way Crossover Bio... | NCT00674310

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

NCT00674310

Sponsor

Roxane Laboratories

Status

Completed

Last Update Posted

Jan 23, 2018Actual

Enrollment

29Actual

Phase

Not Applicable

Conditions

Parkinson's Disease
Restless Leg Syndrome

Interventions

Ropinirole Hydrochloride

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2004

Primary Completion Date

Feb 2004Actual

Completion Date

Feb 2004Actual

First Submitted Date

May 5, 2008

First Submission Date that Met QC Criteria

May 6, 2008

First Posted Date

May 7, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 19, 2018

Last Update Posted Date

Jan 23, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

29Actual

Name	Type	Description	Arm Group Labels	Other Names
Ropinirole Hydrochloride	Drug	Restless Leg Syndrome

Measure	Description	Time Frame
Bioequivalence		Baseline, Two period, seven day washout

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Richard Larouche, M.D.	SFBC Anapharm	Principal Investigator

Condition Browse Module

MeSH Terms

ID	Term
D010300	Parkinson Disease
D012148	Restless Legs Syndrome

Ancestor Terms

ID	Term
D020734	Parkinsonian Disorders
D001480	Basal Ganglia Diseases
D001927	Brain Diseases
D002493	Central Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C046649	ropinirole

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided