Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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 used for Type 2 Diabetes Mellitus. It is a small molecule being developed by Merck & Company, Inc. (MRK) as an investigational treatment for this condition. The drug is currently in Phase 1 clinical development.
Merck & Company, Inc. (MRK) is developing Sitagliptin anhydrous formulation. The company is conducting clinical trials to evaluate this small molecule for the treatment of Type 2 Diabetes Mellitus. The drug is currently in Phase 1 development.
Sitagliptin anhydrous formulation is in Phase 1 clinical development. It is an investigational drug for Type 2 Diabetes Mellitus and has not been approved by regulatory authorities. One Phase 1 trial has been completed.
Sitagliptin anhydrous formulation has one completed clinical trial, NCT00944450, titled "Study of the Bioequivalence of Two Tablet Forms of MK0431 (0431-027)". This Phase 1 trial enrolled 12 participants with Type 2 Diabetes Mellitus and was active-controlled.
Sitagliptin anhydrous formulation is also known as MK0431. The clinical trial NCT00944450 refers to the drug as MK0431, confirming that these names refer to the same investigational compound being developed by Merck & Company, Inc. for Type 2 Diabetes Mellitus.