Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Sitagliptin phosphate anhydrous formulation
Sitagliptin anhydrous formulation · 1 trial · 1 indication
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...
Sitagliptin anhydrous formulation is an investigational small molecule developed by Merck & Company, Inc. (MRK) for type 2 diabetes mellitus. It is a specific anhydrous form of sitagliptin, also known as sitagliptin phosphate anhydrous formulation. It is in Phase 1 clinical development.
Sitagliptin anhydrous formulation is being developed for the treatment of type 2 diabetes mellitus. It is an investigational agent and has not been approved for any indication. Its development is in Phase 1.
Sitagliptin anhydrous formulation targets DPP4 (dipeptidyl peptidase-4). It acts as a DPP4 inhibitor. By inhibiting DPP4, it is designed to increase incretin levels, which may help manage blood glucose in type 2 diabetes mellitus.
Sitagliptin anhydrous formulation is developed by Merck & Company, Inc., which trades under the ticker MRK. Merck is responsible for the clinical development of this investigational formulation.
Sitagliptin anhydrous formulation is in Phase 1 clinical development. It is investigational and has not been approved by the FDA or any regulatory agency. The Phase 1 program includes one completed trial.
Sitagliptin anhydrous formulation has been studied in one completed Phase 1 trial, NCT00944450, titled "Study of the Bioequivalence of Two Tablet Forms of MK0431 (0431-027)." The trial enrolled 12 participants with type 2 diabetes mellitus and was active-controlled and randomized.
Yes, sitagliptin anhydrous formulation is also known as sitagliptin phosphate anhydrous formulation. Both names refer to the same investigational small molecule developed by Merck for type 2 diabetes mellitus.