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

Information source: Roxane Laboratories
ClinicalTrials.gov processed this data on August 23, 2015
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 fasting 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 Und Fasted Conditions

Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

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 fasting 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 findings 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
Last updated: May 21, 2008

Page last updated: August 23, 2015

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