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

Roxane Laboratories

Status: Completed

Conditions: Restless Leg Syndrome; Parkinson's Disease

Treatments: Drug: Ropinirole Hydrochloride

Study type: Interventional

Funder types: Industry

Identifiers

NCT00673088

ROPI-T25-PVFS-1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)