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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ropinirole | Experimental | Ropinirole Hydrochloride ER tablets 2 mg of Dr. Reddy's Laboratories Limited |
|
| Requip | Active Comparator | Requip XL Tablets 2 mg of Glaxosmithkline, USA |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ropinirole | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under curve(AUC) | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dr. Naba Kr Talukdar, MD | GVK Biosciences Pvt. Ltd. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GVK Biosciences Pvt. Ltd | Ameerpet | Hyderabad | 500 038 | India |
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| ID | Term |
|---|---|
| C046649 | ropinirole |
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