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Sitagliptin/Metformin Fed Bioequivalence Study

This study has been completed.
Sponsor:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00929201
First received: June 25, 2009
Last updated: April 21, 2010
Last verified: April 2010
History of Changes

June 25, 2009
April 21, 2010
January 2008
May 2008   (final data collection date for primary outcome measure)
Plasma Area Under the Curve (AUC(0 to Infinity)) for Metformin [ Time Frame: 72 Hours Post Dose ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00929201 on ClinicalTrials.gov Archive Site
Peak Plasma Concentration (Cmax) of Metformin [ Time Frame: 72 Hours Post Dose ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Sitagliptin/Metformin Fed Bioequivalence Study
An Open-Label, Randomized, Two-Period Crossover Definitive Bioequivalence Study With the Final Marketed Image (FMI) Sitagliptin/Metformin Fixed-Dose Combination (FDC) Tablet and Co-Administration of the Sitagliptin and Metformin Individual Tablets After Consumption of a High-Fat Meal in Healthy Adult Subjects

This study will demonstrate the bioequivalence of metformin after single dose administration of sitagliptin/metformin 50/500 mg and concomitant administration of single doses of sitagliptin 50 mg and metformin 500 mg as individual tablets after consumption of a high-fat meal.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Type 2 Diabetes Mellitus
  • Drug: sitagliptin phosphate (+) metformin hydrochloride
    Single dose sitagliptin/metformin 50/500 mg after consumption of a high-fat meal in one of two treatment periods.
  • Drug: Comparator: sitagliptin
    Single dose sitagliptin 50 mg after consumption of a high-fat meal in one of two treatment periods.
  • Drug: Comparator: metformin
    Single dose metformin 500 mg after consumption of a high-fat meal in one of two treatment periods.
  • Active Comparator: A
    Sitagliptin 50 mg and metformin 500 mg individual tablets
    Interventions:
    • Drug: Comparator: sitagliptin
    • Drug: Comparator: metformin
  • Active Comparator: B
    Sitagliptin/Metformin 50 mg/500 mg combination tablet
    Intervention: Drug: sitagliptin phosphate (+) metformin hydrochloride
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
61
June 2008
May 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subject is in good health
  • Subject is a nonsmoker
  • Subject is willing to follow all study guidelines

Exclusion Criteria:

  • Subject has or has a history of any illness or condition that might confound the results of the study or make participation unsafe for the subject
  • Subject is a nursing mother
  • Subject is unwilling to consume the required high-fat breakfast
Both
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00929201
2009_607, MK0431A-080
Not Provided
Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
Merck
Not Provided
Study Director: Medical Monitor Merck
Merck
April 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP