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Ropinirole

Phase 1

Healthy | Small molecule | Other |Dr. Reddy's Laboratories Ltd|Last Updated: Sep 28, 2012

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials2
Total Enrollment96

FDA Designations

No designations recorded

Clinical trial landscape

Ropinirole · 2 trials · 1 indication

Phase 1 2
NCT01627834Bioequivalence Study of Ropinirole Hydrochloride ER Tablets 2 mg Under Fasting ConditionHealthy
COMPLETED48 Analytics
NCT01627847Bioequivalence Study of Ropinirole Hydrochloride ER Tablets 2 mg Under Fed ConditionHealthy
COMPLETED48 Analytics
PHASE1COMPLETED
Bioequivalence Study of Ropinirole Hydrochloride ER Tablets 2 mg Under Fasting Condition
Healthy
NCT0162783448
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PHASE1COMPLETED
Bioequivalence Study of Ropinirole Hydrochloride ER Tablets 2 mg Under Fed Condition
Healthy
NCT0162784748
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Study Endpoints

Primary Endpoints

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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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
RopiniroleEXPERIMENTALRopinirole Hydrochloride ER tablets 2 mg of Dr. Reddy's Laboratories Limited
RequipACTIVE_COMPARATORRequip XL Tablets 2 mg of Glaxosmithkline, USA

Interventions

NameTypeDescription
RopiniroleDRUG -
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Eligibility Criteria

Age Range18 Years to 45 Years
SexALL
Healthy VolunteersYes
Study Sites1

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...

Countries:India
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Frequently asked questions about Ropinirole

What is Ropinirole?

Ropinirole is a small molecule drug being developed by Dr. Reddy's Laboratories Ltd. It is currently in Phase 1 clinical development. The drug is being studied in healthy volunteers for bioequivalence purposes, with two completed trials involving a total of 96 participants.

What is Ropinirole used for?

Ropinirole is being studied in healthy volunteers for bioequivalence trials. These trials compare the generic version of the drug to a reference product to ensure they are equivalent in the body. The drug is not yet approved for any specific medical condition.

Who makes Ropinirole?

Ropinirole is being developed by Dr. Reddy's Laboratories Ltd, a pharmaceutical company listed on the stock exchange under the ticker symbol RDY. The company is conducting Phase 1 clinical trials to evaluate the drug's bioequivalence in healthy subjects.

What phase is Ropinirole in?

Ropinirole is in Phase 1 clinical development. The drug is investigational and has not been approved by regulatory authorities. Two Phase 1 trials have been completed, both focusing on bioequivalence in healthy volunteers.

What clinical trials is Ropinirole in?

Ropinirole has two completed Phase 1 clinical trials. NCT01627834 is a bioequivalence study of Ropinirole Hydrochloride ER Tablets 2 mg under fasting conditions, and NCT01627847 is the same study under fed conditions. Both trials enrolled 48 healthy participants each in India.

Is Ropinirole the same as Ropinirole Hydrochloride?

Ropinirole is the active ingredient in the drug product Ropinirole Hydrochloride. The clinical trials for Ropinirole specifically test Ropinirole Hydrochloride ER Tablets 2 mg, which is the salt form of the drug used in the formulation.