A Single-Dose, 2-Period, 2-Treatment, 2-Way Crossover Bioequivalency Study of Ropinirole 0.25 mg Tablets Under Fed Conditions
Information source: Roxane Laboratories
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Parkinson's Disease; Restless Leg Syndrome
Intervention: Ropinirole Hydrochloride (Drug)
Phase: N/A
Status: Completed
Sponsored by: Roxane Laboratories Official(s) and/or principal investigator(s):
Richard Larouche, M.D., Principal Investigator, Affiliation: SFBC Anapharm
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.
Clinical Details
Official title: A Single-Dose, 2-Period, 2-Treatment, 2-Way Crossover Bioequivalency Study of Ropinirole 0.25 mg Tablets Under Fed Conditions
Study design: Treatment, Randomized, Open Label, Crossover Assignment, Bio-equivalence Study
Primary outcome: Bioequivalence
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, randomized, 2-treatment, 2-period, 2-sequence cross-over design.
Eligibility
Minimum age: 18 Years.
Maximum age: 45 Years.
Gender(s): Both.
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.
Locations and Contacts
Additional Information
Starting date: February 2004
Ending date: February 2004
Last updated: May 20, 2008
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