Approval Probability
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Adjusted LOA
ML Risk
BROMOCRIPTINE, USP · 2 trials · 1 indication
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | Metoclopramide Hydrochloride Injection Sandoz Standard 5mg/mL (10mg/2mL)and BROMOCRIPTINE MESYLATE CAPSULES, USP 5 mg |
| 2 | ACTIVE_COMPARATOR | Metoclopramide Hydrochloride Injection Sandoz Standard 5mg/mL (10mg/2mL) and Parlodel® (bromocriptine mesylate) capsules, USP 5 mg |
| Name | Type | Description |
|---|---|---|
| BROMOCRIPTINE MESYLATE CAPSULES, USP 5 mg | DRUG | 4x2.5mg bromocriptine mesylate, single dose fed; with 10mg metoclopramide HCl prophylactic injection |
| Parlodel® (bromocriptine mesylate) capsules, USP 5 mg | DRUG | 4x2.5mg bromocriptine mesylate, single dose fed; with 10mg metoclopramide HCl prophylactic injection |
Inclusion Criteria: * Healthy adult male or female volunteers, 18-45 years of age. * Subjects will be continuous non-smokers for at least 3 months prior to the first dose or consistent moderate smokers (fewer than 10 cigarettes per day) for at least 3 months prior to the first dosing. * Weighi...
BROMOCRIPTINE, USP is a small molecule drug being developed by Viatris Inc. (VTRS). It is currently in Phase 1 clinical development. The drug has been studied in healthy volunteers in clinical trials conducted in Canada.
BROMOCRIPTINE, USP is being studied in healthy volunteers. The clinical trials for this drug are Phase 1 studies that enroll healthy participants. The drug is not approved for any specific medical condition and remains in clinical development.
BROMOCRIPTINE, USP is being developed by Viatris Inc., a company traded on the stock exchange under the ticker symbol VTRS. Viatris is the sponsor of the clinical trials for this drug.
BROMOCRIPTINE, USP is in Phase 1 clinical development. The drug is investigational and has not been approved by regulatory authorities. It is being studied in early-stage clinical trials involving healthy volunteers.
BROMOCRIPTINE, USP has been studied in two completed Phase 1 clinical trials: NCT00649168 and NCT00650520. Both trials were conducted in Canada and enrolled healthy volunteers. The first trial studied 5 mg capsules and the second studied 2.5 mg tablets.
BROMOCRIPTINE, USP is being studied in formulations that are compared to Parlodel. The clinical trials for this drug reference Parlodel in their titles, indicating that BROMOCRIPTINE, USP is being evaluated as a potential generic or alternative version of Parlodel.