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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00648362 | Fasting Study of Glimepiride Tablets 1 mg to Amaryl® Tablets 1 mg | PHASE1 | COMPLETED | 40 | — | — | Nov 1, 2004 | Dec 1, 2004 | Apr 24, 2024 | 1 | United States |
| NCT00650533 | Food Study of Glimepiride Tablets 1 mg to Amaryl® Tablets 1 mg | PHASE1 | COMPLETED | 40 | — | — | Nov 1, 2004 | Dec 1, 2004 | Apr 24, 2024 | 1 | United States |
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | Glimepiride Tablets 1 mg |
| 2 | ACTIVE_COMPARATOR | Amaryl® Tablets 1 mg |
| Name | Type | Description |
|---|---|---|
| Glimepiride Tablets 1 mg | DRUG | 1mg, single dose fasting |
| Amaryl® Tablets 1 mg | DRUG | 1mg, single dose fasting |
Inclusion Criteria: 1. Age: 18 years and older. 2. Sex: Male and/or non-pregnant, non-lactating female. a. Women of childbearing potential must have a negative serum (Beta HCG) pregnancy test performed within 14 days prior to the start of the study and on the evening prior to each dose administrati...