Overview

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

Status:
Completed
Trial end date:
2004-02-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
N/A
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Roxane Laboratories
Treatments:
Ropinirole
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.