Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Ropinirole · 2 trials · 1 indication
Bioequivalence based on Cmax.
Bioequivalence based on AUC0-t.
Bioequivalence based on AUC0-inf.
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | - |
| 2 | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Ropinirole HCl 0.25 mg Tablets | DRUG | 1 x 0.25 mg, single dose fed |
| Requip® 0.25 mg Tablets | DRUG | 1 x 0.25 mg, single dose fed |
Inclusion Criteria: * Males and females, 18 to 45 years of age (inclusive), with a body mass index (BMI) of 19-30 kg/m² inclusive and weighing at least 120 lbs. * Sitting (at least 5 minutes) blood pressure of at least 100/70 and sitting pulse of at least 60 b.p.m. * Good health as determined by la...
Ropinirole is a small molecule drug being developed by Teva Pharmaceutical Industries Limited (TEVA). It is currently in Phase 1 clinical development for use in healthy volunteers. The drug is being studied in bioavailability trials to assess how it is absorbed and processed by the body.
Ropinirole is being studied for use in healthy volunteers. It is currently in Phase 1 clinical trials that evaluate the drug's bioavailability under fasting and fed conditions. These trials are designed to measure how the drug is absorbed and how food affects its absorption.
Ropinirole is developed by Teva Pharmaceutical Industries Limited, a company traded under the ticker TEVA. Teva is conducting Phase 1 clinical trials of Ropinirole in the United States to study its bioavailability in healthy adult volunteers.
Ropinirole is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. Two Phase 1 trials have been completed, both involving healthy volunteers, with a total enrollment of 90 participants.
Ropinirole has two completed Phase 1 clinical trials. NCT00829504 studied Ropinirole 0.25 mg tablets under fasting conditions with 44 participants. NCT00830219 studied the relative bioavailability of two Ropinirole 0.25 mg tablets under fed conditions with 46 participants. Both trials were conducted in the United States.
Ropinirole is the active ingredient in the drug being studied. The clinical trials reference Ropinirole 0.25 mg tablets, which contain the drug in tablet form. The trials do not specify a salt form, so it is not stated whether the drug is the hydrochloride salt.