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Also known as Requip
Ropinirole · 2 trials · 1 indication
| Arm | Type | Description |
|---|---|---|
| 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 |
|---|---|---|
| Ropinirole | DRUG | - |
Inclusion Criteria: 1. Healthy human subjects aged between 18 and 45 years (including both). 2. Subjects with a BMI between 18.5 - 24.9 Kg/m2 (including both) but body weight not less than 45 Kgs. 3. Subjects with normal health as determined by personal medical history, clinical examination, and la...
Ropinirole is a small molecule drug developed by Dr. Reddy's Laboratories Ltd (ticker RDY). It is a dopamine receptor agonist that targets DRD2, DRD3, and DRD4. The program is in Phase 1 development, and the specific therapeutic indication has not been disclosed. It is being studied as an extended-release tablet formulation.
Ropinirole targets the dopamine receptors DRD2, DRD3, and DRD4. It acts as an agonist at these receptors, meaning it activates them. This target class is central to its mechanism of action as a small molecule therapeutic developed by Dr. Reddy's Laboratories Ltd.
Ropinirole is developed by Dr. Reddy's Laboratories Ltd, which trades under the ticker RDY. The company is running the clinical development program for this small molecule dopamine receptor agonist, including the bioequivalence studies conducted in India.
Ropinirole is in Phase 1 clinical development. Two Phase 1 trials have been completed, and no trials are currently active. The program is investigational and has not been approved. Both completed studies were bioequivalence studies of the extended-release tablet formulation.
Ropinirole has been studied in two completed Phase 1 trials: NCT01627847, a bioequivalence study of ropinirole hydrochloride ER tablets 2 mg under fed conditions, and NCT01627834, the same formulation under fasting conditions. Both enrolled 48 healthy volunteers in India, for a total enrollment of 96 participants.
Yes. Both completed Phase 1 trials of Ropinirole were randomized and used an active control design. They were not double blind. Each study enrolled 48 healthy adult volunteers of all sexes, aged 18 years and older, and was conducted in India.