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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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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)

Participant Flow for 2 periods

Period 1:   Period 1
    100 mg MK0431 Anhydrous Then 100 mg MK0431 Monohydrate   100 mg MK0431 Monohydrate Then 100 mg MK0431 Anhydrous
STARTED   6   6 
COMPLETED   6   6 
NOT COMPLETED   0   0 

Period 2:   Period 2
    100 mg MK0431 Anhydrous Then 100 mg MK0431 Monohydrate   100 mg MK0431 Monohydrate Then 100 mg MK0431 Anhydrous
STARTED   6   6 
COMPLETED   6   6 
NOT COMPLETED   0   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
All Participants No text entered.

Baseline Measures
   All Participants 
Overall Participants Analyzed 
[Units: Participants]
 12 
Age 
[Units: Years]
Mean (Full Range)
 45.3 
 (41 to 54) 
Gender 
[Units: Participants]
 
Female   6 
Male   6 
Height 
[Units: Centimeters]
Mean (Full Range)
 170.5 
 (156.5 to 179.0) 
Weight 
[Units: Kilograms]
Mean (Full Range)
 75.3 
 (56.6 to 88.3) 


  Outcome Measures

1.  Primary:   Area Under the Curve (AUC(0 to Infinity)) Following Single Dose Administration of the Anhydrous and Monohydrate Forms of MK0431 (Sitagliptin)   [ Time Frame: Through 72 Hours Following the Administration of the Medication ]

2.  Primary:   Peak Plasma Concentration (Cmax) Following Single Dose Administration of the Anhydrous and Monohydrate Forms of MK0431 (Sitagliptin)   [ Time Frame: Through 72 Hours Following the Administration of the Medication ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
phone: 1-800-672-6372
e-mail: ClinicalTrialsDisclosure@merck.com



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