This is an open label, randomised, balanced, two-treatment, two-period, two-sequence, crossover, oral bioequivalence study.
The objective of this study was to determine the single-dose oral bioequivalence of Ropinirole Hydrochloride Extended Release Tablets 2 mg of Dr. Reddy's Laboratories Limited, India with REQUIP® XL (Ropinirole) 2 mg ER Tablets of Glaxosmithkline, USA, in normal, healthy, adult, human subjects under fasting condition.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
48
GVK Biosciences Pvt. Ltd
Ameerpet, Hyderabad, India
Area under curve(AUC)
Time frame: Pre-dose (before dosing, in the morning of the day of dosing) and at 1.00, 2.00, 3.00,4.00, 5.00, 6.00, 7.00, 8.00, 9.00, 10.00, 11.00, 12.00, 13.00, 14.00, 15.00, 16.00, 17.00, 18.00,20.00, 24.00, 30.00, 36.00, 48.00 and 60.00 hours after dosing.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.