Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00650520 | Fed Study of (Parlodel®) 2.5 mg Bromocriptine Mesylate Tablets | PHASE1 | COMPLETED | 119 | — | — | May 1, 2007 | Jul 1, 2007 | Apr 24, 2024 | 1 | Canada |
| NCT00649168 | Fed Study of (Parlodel®) Bromocriptine Mesylate Capsules 5 mg | PHASE1 | COMPLETED | 120 | — | — | Apr 1, 2007 | Jun 1, 2007 | Apr 24, 2024 | 1 | Canada |
| 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...