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
• 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
• 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.

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease
• Restless Leg Syndrome
• Restless Legs Syndrome

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