Trial Outcomes & Findings for Study of the Bioequivalence of Two Tablet Forms of MK0431 (0431-027) (NCT NCT00944450)
NCT ID: NCT00944450
Last Updated: 2015-08-19
Results Overview
Area Under the Plasma Concentration-Time Curve and peak concentration of the Anhydrous and Monohydrate Forms of MK0431 (Sitagliptin)
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
12 participants
Primary outcome timeframe
Through 72 Hours Following the Administration of the Medication
Results posted on
2015-08-19
Participant Flow
Participant milestones
| Measure |
100 mg MK0431 Anhydrous Then 100 mg MK0431 Monohydrate
Single dose sitagliptin 100 mg tablets \[monohydrate Final Market Image (FMI) form\] in one of two treatment periods.
|
100 mg MK0431 Monohydrate Then 100 mg MK0431 Anhydrous
100 mg MK0431 monohydrate (Phase III/FMI formulation) then 100 mg MK0431 anhydrous (Phase IIB formulation)
|
|---|---|---|
|
Period 1
STARTED
|
6
|
6
|
|
Period 1
COMPLETED
|
6
|
6
|
|
Period 1
NOT COMPLETED
|
0
|
0
|
|
Period 2
STARTED
|
6
|
6
|
|
Period 2
COMPLETED
|
6
|
6
|
|
Period 2
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of the Bioequivalence of Two Tablet Forms of MK0431 (0431-027)
Baseline characteristics by cohort
| Measure |
All Participants
n=12 Participants
|
|---|---|
|
Age, Continuous
|
45.3 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
|
Height
|
170.5 Centimeters
n=5 Participants
|
|
Weight
|
75.3 Kilograms
n=5 Participants
|
PRIMARY outcome
Timeframe: Through 72 Hours Following the Administration of the MedicationPopulation: Healthy Male and Female Subjects
Area Under the Plasma Concentration-Time Curve and peak concentration of the Anhydrous and Monohydrate Forms of MK0431 (Sitagliptin)
Outcome measures
| Measure |
100 mg MK0431 Anhydrous
n=12 Participants
100 mg MK0431 anhydrous (Phase IIB) formulation administered as a single dose.
|
100 mg MK0431 Monohydrate
n=12 Participants
100 mg MK0431 monohydrate (Phase III/FMI) formulation administered as a single dose.
|
|---|---|---|
|
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
|
8.78 μmol*hr/L
Standard Deviation 0.86
|
PRIMARY outcome
Timeframe: Through 72 Hours Following the Administration of the MedicationPopulation: Healthy Male and Female Subjects
Peak Plasma concentration (Cmax) for the Anhydrous and Monohydrate Forms of MK0431 (Sitagliptin)
Outcome measures
| Measure |
100 mg MK0431 Anhydrous
n=12 Participants
100 mg MK0431 anhydrous (Phase IIB) formulation administered as a single dose.
|
100 mg MK0431 Monohydrate
n=12 Participants
100 mg MK0431 monohydrate (Phase III/FMI) formulation administered as a single dose.
|
|---|---|---|
|
Peak Plasma Concentration (Cmax) Following Single Dose Administration of the Anhydrous and Monohydrate Forms of MK0431 (Sitagliptin)
|
799 μmol/L
Standard Deviation 164
|
856 μmol/L
Standard Deviation 180
|
Adverse Events
100 mg MK0431 Anhydrous Then 100 mg MK0431 Monohydrate
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
100 mg MK0431 Monohydrate Then 100 mg MK0431 Anhydrous
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
100 mg MK0431 Anhydrous Then 100 mg MK0431 Monohydrate
n=12 participants at risk
Single dose sitagliptin 100 mg tablets \[monohydrate Final Market Image (FMI) form\] in one of two treatment periods.
|
100 mg MK0431 Monohydrate Then 100 mg MK0431 Anhydrous
n=12 participants at risk
100 mg MK0431 monohydrate (Phase III/FMI formulation) then 100 mg MK0431 anhydrous (Phase IIB formulation)
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
8.3%
1/12
|
8.3%
1/12
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/12
|
8.3%
1/12
|
|
General disorders
Asthenia
|
0.00%
0/12
|
8.3%
1/12
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
0.00%
0/12
|
8.3%
1/12
|
|
Injury, poisoning and procedural complications
Thermal Burn
|
0.00%
0/12
|
8.3%
1/12
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Stiffness
|
0.00%
0/12
|
8.3%
1/12
|
|
Nervous system disorders
Dizziness
|
0.00%
0/12
|
8.3%
1/12
|
|
Nervous system disorders
Headache
|
25.0%
3/12
|
16.7%
2/12
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER