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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01372306 | Galantamine Bioequivalence Study of Dr. Reddy's Under Fed Condition | PHASE1 | COMPLETED | 24 | — | — | Oct 1, 2004 | Nov 1, 2004 | Jun 30, 2011 | - | — |
| Arm | Type | Description |
|---|---|---|
| Galantamine | EXPERIMENTAL | Galantamine Hydrobromide Tablets of Dr. Reddy's |
| Reminyl | ACTIVE_COMPARATOR | Reminyl 4 mg tablets of Janssen Pharmaceutical Products |
| Name | Type | Description |
|---|---|---|
| Reminyl | DRUG | Galantamine Hydrobromide Tablets of Dr. Reddy's Laboratories Limited |
Inclusion Criteria: Subject candidates must fulfill all of the following inclusion criteria to be eligible for participation in the studyI unless otherwise specified: * Healthy adult male volunteers, 18-55 years of age; * Weighing at least 60 kg and within 15% of their ideal weights (Table of "Des...