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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00944450 | Study of the Bioequivalence of Two Tablet Forms of MK0431 (0431-027) | PHASE1 | COMPLETED | 12 | — | — | Aug 1, 2004 | Nov 1, 2004 | Aug 19, 2015 | - | — |
Area Under the Plasma Concentration-Time Curve and peak concentration of the Anhydrous and Monohydrate Forms of MK0431 (Sitagliptin)
Peak Plasma concentration (Cmax) for the Anhydrous and Monohydrate Forms of MK0431 (Sitagliptin)
| Arm | Type | Description |
|---|---|---|
| 1 | ACTIVE_COMPARATOR | Sitagliptin anhydrous formulation |
| 2 | ACTIVE_COMPARATOR | Sitagliptin monohydrate FMI formulation |
| Name | Type | Description |
|---|---|---|
| Sitagliptin phosphate anhydrous formulation | DRUG | Single dose sitagliptin 100 mg tablets (anhydrous form) in one of two treatment periods. |
| Comparator: sitagliptin phosphate monohydrate form | DRUG | Single dose sitagliptin 100 mg tablets \[monohydrate Final Market Image (FMI) form\] in one of two treatment periods. |
Inclusion Criteria: * Subject is in good health * Female subjects must have a negative pregnancy test * Subject is within 30% of ideal body weight * Subject does not smoke * Subject agrees to follow the study guidelines Exclusion Criteria: * Subject has a history of any illness that might confoun...