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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 developed by Viatris Inc. (ticker: VTRS). It is being studied in Phase 1 clinical trials in healthy volunteers. The drug is also known as BROMOCRIPTINE MESYLATE CAPSULES, USP 5 mg. It acts as an agonist at the DRD2, DRD3, and DRD4 receptors.
BROMOCRIPTINE, USP targets the dopamine receptors DRD2, DRD3, and DRD4. It functions as an agonist at these receptors. This target profile is consistent with its classification as a small molecule in the agonist class.
BROMOCRIPTINE, USP is being developed by Viatris Inc., which trades under the ticker symbol VTRS. Viatris is the company responsible for the clinical development of this drug candidate.
BROMOCRIPTINE, USP is in Phase 1 clinical development. It is investigational and has not been approved by the FDA for any indication. The Phase 1 trials have been completed.
BROMOCRIPTINE, USP has been studied in two completed Phase 1 trials: NCT00650520, which tested 2.5 mg bromocriptine mesylate tablets in 119 healthy volunteers in Canada, and NCT00649168, which tested 5 mg bromocriptine mesylate capsules in 120 healthy volunteers in Canada. Both trials enrolled adults aged 18 years and older.