Status:
COMPLETED
A Single Dose, 2-Period, 2-Treatment, 2-Way Crossover Bioequivalency Study of Ropinirole 0.25 mg Tablets Und Fasted 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 fasting conditions using a single-do...
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 fasting conditions using a single-do...
Eligibility Criteria
Inclusion
- No clinically significant abnormal findings 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 :
30 Patients enrolled
Trial Details
Trial ID
NCT00673088
Start Date
February 1 2004
End Date
February 1 2004
Last Update
January 23 2018
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