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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00840476 | Meloxicam 15 mg Tablets Under Fasting Conditions | PHASE1 | COMPLETED | 28 | — | — | Feb 1, 2004 | Feb 1, 2004 | Aug 19, 2024 | 1 | Canada |
| NCT00840879 | Meloxicam 15 mg Tablets Under Non-Fasting Conditions | PHASE1 | COMPLETED | 28 | — | — | Feb 1, 2004 | Feb 1, 2004 | Aug 19, 2024 | 1 | Canada |
Bioequivalence based on Cmax
Bioequivalence based on AUC0-inf
Bioequivalence based on AUC0-t
| Arm | Type | Description |
|---|---|---|
| Meloxicam | EXPERIMENTAL | Meloxicam 15 mg Tablet (test) dosed in first period followed by Mobic® 15 mg Tablet (reference) dosed in second period |
| Mobic® | ACTIVE_COMPARATOR | Mobic® 15 mg Tablet (reference) dosed in first period followed by Meloxicam 15 mg Tablet (test) dosed in second period |
| Name | Type | Description |
|---|---|---|
| Meloxicam 15 mg Tablets | DRUG | 1 x 15 mg, single-dose fasting |
| Mobic® 15 mg Tablets | DRUG | 1 x 15 mg, single-dose fasting |
Inclusion Criteria: * Non-smoking male or female with a minimum age of 18 years (i.e. non-smoker or non tobacco user for at least 90 days prior to pre-study medical). * Body mass Index (BMI = weight/height²) greater than or equal to 18.5 kg/m² and less than or equal to 29.9 kg/m². * Availability of...