Status:
COMPLETED
A Single-Dose, 2-Period, 2-Treatment, 2-Way Crossover Bioequivalency Study of Ropinirole 0.25 mg Tablets Under Fed Conditions
Lead Sponsor:
Roxane Laboratories
Conditions:
Parkinson's Disease
Restless Leg Syndrome
Eligibility:
All Genders
18-45 years
Phase:
NA
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, ...
Detailed 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, ...
Eligibility Criteria
Inclusion
- No clinically significant abnormal finding on the physical examination, medical history, or clinical laboratory results during screening
Exclusion
- 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.
Key Trial Info
Start Date :
February 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2004
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT00674310
Start Date
February 1 2004
End Date
February 1 2004
Last Update
January 23 2018
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