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Study of the Bioequivalence of Two Tablet Forms of MK0431 (0431-027)

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ClinicalTrials.gov Identifier: NCT00944450
Recruitment Status : Completed
First Posted : July 23, 2009
Results First Posted : April 27, 2010
Last Update Posted : August 19, 2015
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Type 2 Diabetes Mellitus
Interventions Drug: Sitagliptin phosphate anhydrous formulation
Drug: Comparator: sitagliptin phosphate monohydrate form
Enrollment 12
Recruitment Details  
Pre-assignment Details  
Arm/Group Title 100 mg MK0431 Anhydrous Then 100 mg MK0431 Monohydrate 100 mg MK0431 Monohydrate Then 100 mg MK0431 Anhydrous
Hide Arm/Group Description Single dose sitagliptin 100 mg tablets [monohydrate Final Market Image (FMI) form] in one of two treatment periods. 100 mg MK0431 monohydrate (Phase III/FMI formulation) then 100 mg MK0431 anhydrous (Phase IIB formulation)
Period Title: Period 1
Started 6 6
Completed 6 6
Not Completed 0 0
Period Title: Period 2
Started 6 6
Completed 6 6
Not Completed 0 0
Arm/Group Title All Participants
Hide Arm/Group Description [Not Specified]
Overall Number of Baseline Participants 12
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 12 participants
45.3
(41 to 54)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants
Female
6
  50.0%
Male
6
  50.0%
Height  
Mean (Full Range)
Unit of measure:  Centimeters
Number Analyzed 12 participants
170.5
(156.5 to 179.0)
Weight  
Mean (Full Range)
Unit of measure:  Kilograms
Number Analyzed 12 participants
75.3
(56.6 to 88.3)
1.Primary Outcome
Title Area Under the Curve (AUC(0 to Infinity)) Following Single Dose Administration of the Anhydrous and Monohydrate Forms of MK0431 (Sitagliptin)
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Healthy Male and Female Subjects
Arm/Group Title 100 mg MK0431 Anhydrous 100 mg MK0431 Monohydrate
Hide Arm/Group Description:
100 mg MK0431 anhydrous (Phase IIB) formulation administered as a single dose.
100 mg MK0431 monohydrate (Phase III/FMI) formulation administered as a single dose.
Overall Number of Participants Analyzed 12 12
Geometric Mean (Standard Deviation)
Unit of Measure: μmol*hr/L
8.38  (0.77) 8.78  (0.86)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 100 mg MK0431 Anhydrous, 100 mg MK0431 Monohydrate
Comments 100 mg MK0431 monohydrate (Phase III/FMI formulation) (B) vs. 100 mg MK0431 anhydrous (Phase IIB formulation) (A)
Type of Statistical Test Non-Inferiority or Equivalence
Comments Pre-specified equivalence bounds = (0.80, 1.25) for AUC geometric mean ratio (B/A)
Method of Estimation Estimation Parameter Geometric Mean Ratio
Estimated Value 1.05
Confidence Interval 90%
1.02 to 1.07
Estimation Comments [Not Specified]
2.Primary Outcome
Title Peak Plasma Concentration (Cmax) Following Single Dose Administration of the Anhydrous and Monohydrate Forms of MK0431 (Sitagliptin)
Hide Description Peak Plasma concentration (Cmax) for the Anhydrous and Monohydrate Forms of MK0431 (Sitagliptin)
Time Frame Through 72 Hours Following the Administration of the Medication
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Healthy Male and Female Subjects
Arm/Group Title 100 mg MK0431 Anhydrous 100 mg MK0431 Monohydrate
Hide Arm/Group Description:
100 mg MK0431 anhydrous (Phase IIB) formulation administered as a single dose.
100 mg MK0431 monohydrate (Phase III/FMI) formulation administered as a single dose.
Overall Number of Participants Analyzed 12 12
Geometric Mean (Standard Deviation)
Unit of Measure: μmol/L
799  (164) 856  (180)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 100 mg MK0431 Anhydrous, 100 mg MK0431 Monohydrate
Comments 100 mg MK0431 monohydrate (Phase III/FMI formulation) (B) vs. 100 mg MK0431 anhydrous (Phase IIB formulation) (A)
Type of Statistical Test Non-Inferiority or Equivalence
Comments Pre-specified equivalence bounds = (0.80, 1.25) for Cmax geometric mean ratio (B/A)
Method of Estimation Estimation Parameter Geometric Mean Ratio
Estimated Value 1.07
Confidence Interval 90%
0.94 to 1.22
Estimation Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 100 mg MK0431 Anhydrous Then 100 mg MK0431 Monohydrate 100 mg MK0431 Monohydrate Then 100 mg MK0431 Anhydrous
Hide Arm/Group Description Single dose sitagliptin 100 mg tablets [monohydrate Final Market Image (FMI) form] in one of two treatment periods. 100 mg MK0431 monohydrate (Phase III/FMI formulation) then 100 mg MK0431 anhydrous (Phase IIB formulation)
All-Cause Mortality
100 mg MK0431 Anhydrous Then 100 mg MK0431 Monohydrate 100 mg MK0431 Monohydrate Then 100 mg MK0431 Anhydrous
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
100 mg MK0431 Anhydrous Then 100 mg MK0431 Monohydrate 100 mg MK0431 Monohydrate Then 100 mg MK0431 Anhydrous
Affected / at Risk (%) Affected / at Risk (%)
Total   0/12 (0.00%)   0/12 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
100 mg MK0431 Anhydrous Then 100 mg MK0431 Monohydrate 100 mg MK0431 Monohydrate Then 100 mg MK0431 Anhydrous
Affected / at Risk (%) Affected / at Risk (%)
Total   3/12 (25.00%)   5/12 (41.67%) 
Gastrointestinal disorders     
Nausea * 1  1/12 (8.33%)  1/12 (8.33%) 
Vomiting * 1  0/12 (0.00%)  1/12 (8.33%) 
General disorders     
Asthenia * 1  0/12 (0.00%)  1/12 (8.33%) 
Infections and infestations     
Upper Respiratory Tract Infection * 1  0/12 (0.00%)  1/12 (8.33%) 
Injury, poisoning and procedural complications     
Thermal Burn * 1  0/12 (0.00%)  1/12 (8.33%) 
Musculoskeletal and connective tissue disorders     
Musculoskeletal Stiffness * 1  0/12 (0.00%)  1/12 (8.33%) 
Nervous system disorders     
Dizziness * 1  0/12 (0.00%)  1/12 (8.33%) 
Headache * 1  3/12 (25.00%)  2/12 (16.67%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 12.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00944450     History of Changes
Other Study ID Numbers: 0431-027
MK0431-027
2009_614
First Submitted: July 21, 2009
First Posted: July 23, 2009
Results First Submitted: February 24, 2010
Results First Posted: April 27, 2010
Last Update Posted: August 19, 2015