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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00835172 | Glimepiride 4 mg Tablets Under Non-Fasting Conditions | PHASE1 | COMPLETED | 32 | — | — | Mar 1, 2003 | Mar 1, 2003 | Aug 20, 2024 | 1 | United States |
| NCT00834340 | Glimepiride 4 mg Tablets Under Fasting Conditions | PHASE1 | COMPLETED | 32 | — | — | Feb 1, 2003 | Mar 1, 2003 | Aug 19, 2024 | 1 | United States |
Bioequivalence based on Cmax
Bioequivalence based on AUCinf
Bioequivalence based on AUC0-t
Bioequivalence based on AUC0-t
| Arm | Type | Description |
|---|---|---|
| Glimepiride | EXPERIMENTAL | Glimepiride 4 mg Tablet (test) dosed in first period followed by Amaryl® 4 mg Tablet (reference) dosed in second period |
| Amaryl® | ACTIVE_COMPARATOR | Amaryl® 4 mg Tablet (reference) dosed in first period followed by Glimepiride 4 mg Tablet (test) dosed in second period |
| Name | Type | Description |
|---|---|---|
| Glimepiride 4 mg Tablets | DRUG | 1 x 4 mg, single-dose non-fasting |
| AMARYL® 4 mg Tablets | DRUG | 1 x 4 mg, single-dose non-fasting |
Inclusion Criteria: * All subjects selected for this study will be non-smokers at least 18 years of age. Subjects will have a BMI (body mass index) of 30 or less. * Each subject shall be given a general physical examination within 28 days of initiation of the study. Such examination includes, but i...