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NCT00674310 Clinical Trial

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

Parkinson's Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00674310
Other study ID # ROPI-T25-PVFD-1
Secondary ID
Status Completed
Phase N/A
First received May 5, 2008
Last updated January 19, 2018
Start date February 2004
Est. completion date February 2004

Study information
Verified date January 2018
Source West-Ward Pharmaceutical
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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

Recruitment information / eligibility
Status Completed
Enrollment 29
Est. completion date February 2004
Est. primary completion date February 2004
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 45 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Ropinirole Hydrochloride
Restless Leg Syndrome

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Roxane Laboratories

Outcome
Type Measure Description Time frame Safety issue
Primary Bioequivalence Baseline, Two period, seven day washout
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