Type 2 Diabetes Mellitus
Conditions
Brief summary
This study will establish that the MK0431 100 mg anhydrous formulation tablets are bioequivalent to the MK0431 100 mg monohydrate final market image (FMI) tablets.
Interventions
DRUGSitagliptin phosphate anhydrous formulation
Single dose sitagliptin 100 mg tablets (anhydrous form) in one of two treatment periods.
DRUGComparator: sitagliptin phosphate monohydrate form
Single dose sitagliptin 100 mg tablets \[monohydrate Final Market Image (FMI) form\] in one of two treatment periods.
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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 confound the results of the study or make participation unsafe for the subject * Subject has a history of hypoglycemia * Subject has a history of any hepatic disease * Subject is taking any oral, parenteral, topical or implantable contraceptives
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area Under the Curve (AUC(0 to Infinity)) Following Single Dose Administration of the Anhydrous and Monohydrate Forms of MK0431 (Sitagliptin) | Through 72 Hours Following the Administration of the Medication | Area Under the Plasma Concentration-Time Curve and peak concentration of the Anhydrous and Monohydrate Forms of MK0431 (Sitagliptin) |
| Peak Plasma Concentration (Cmax) Following Single Dose Administration of the Anhydrous and Monohydrate Forms of MK0431 (Sitagliptin) | Through 72 Hours Following the Administration of the Medication | Peak Plasma concentration (Cmax) for the Anhydrous and Monohydrate Forms of MK0431 (Sitagliptin) |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Participants | 12 |
| Total | 12 |
Baseline characteristics
| Characteristic | All Participants |
|---|---|
| Age, Continuous | 45.3 years |
| Height | 170.5 Centimeters |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 6 Participants |
| Weight | 75.3 Kilograms |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 3 / 12 | 5 / 12 |
| serious Total, serious adverse events | 0 / 12 | 0 / 12 |
Outcome results
Primary
Area Under the Curve (AUC(0 to Infinity)) Following Single Dose Administration of the Anhydrous and Monohydrate Forms of MK0431 (Sitagliptin)
Area Under the Plasma Concentration-Time Curve and peak concentration of the Anhydrous and Monohydrate Forms of MK0431 (Sitagliptin)
Time frame: Through 72 Hours Following the Administration of the Medication
Population: Healthy Male and Female Subjects
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| 100 mg MK0431 Anhydrous | Area Under the Curve (AUC(0 to Infinity)) Following Single Dose Administration of the Anhydrous and Monohydrate Forms of MK0431 (Sitagliptin) | 8.38 μmol*hr/L | Standard Deviation 0.77 |
| 100 mg MK0431 Monohydrate | Area Under the Curve (AUC(0 to Infinity)) Following Single Dose Administration of the Anhydrous and Monohydrate Forms of MK0431 (Sitagliptin) | 8.78 μmol*hr/L | Standard Deviation 0.86 |
Comparison: 100 mg MK0431 monohydrate (Phase III/FMI formulation) (B) vs. 100 mg MK0431 anhydrous (Phase IIB formulation) (A)90% CI: [1.02, 1.07]
Primary
Peak Plasma Concentration (Cmax) Following Single Dose Administration of the Anhydrous and Monohydrate Forms of MK0431 (Sitagliptin)
Peak Plasma concentration (Cmax) for the Anhydrous and Monohydrate Forms of MK0431 (Sitagliptin)
Time frame: Through 72 Hours Following the Administration of the Medication
Population: Healthy Male and Female Subjects
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| 100 mg MK0431 Anhydrous | Peak Plasma Concentration (Cmax) Following Single Dose Administration of the Anhydrous and Monohydrate Forms of MK0431 (Sitagliptin) | 799 μmol/L | Standard Deviation 164 |
| 100 mg MK0431 Monohydrate | Peak Plasma Concentration (Cmax) Following Single Dose Administration of the Anhydrous and Monohydrate Forms of MK0431 (Sitagliptin) | 856 μmol/L | Standard Deviation 180 |
Comparison: 100 mg MK0431 monohydrate (Phase III/FMI formulation) (B) vs. 100 mg MK0431 anhydrous (Phase IIB formulation) (A)90% CI: [0.94, 1.22]