A Study to Demonstrate the Bioequivalence of Sitagliptin/Metformin Combination Tablets and Concomitant Administration of Sitagliptin and Metformin as Individual Tablets (0431A-048)
An Open-label, Randomized Two-Part, Two-Period Crossover Study to Demonstrate the Definitive Bioequivalence After Administration of Final Market Image (FMI) Sitagliptin /Metformin 50/500 mg and 50/1000 mg Fixed Dose Combination (FDC) and Concomitant Administration of 50 mg Doses of Sitagliptin and 500 or 1000 mg Doses of Metformin as Individual Tablets
3 other identifiers
interventional
48
0 countries
N/A
Brief Summary
A two-part study to demonstrate the bioequivalence of a single dose of the Final Market Image (FMI) of sitagliptin /metformin (50/500 and 50/1000 mg) Fixed-Dose Combination (FDC) tablet and co-administration of a single dose of sitagliptin (50 mg) and metformin ( 500 or 1000 mg) as individual tablets. Subject will only participate in one part, receiving treatment A and B (Part I) or Treatment C and D (Part II).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 type-2-diabetes
Started Dec 2005
Shorter than P25 for phase_1 type-2-diabetes
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2006
CompletedFirst Submitted
Initial submission to the registry
August 18, 2009
CompletedFirst Posted
Study publicly available on registry
August 19, 2009
CompletedNovember 13, 2019
November 1, 2019
Same day
August 18, 2009
November 8, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
The area under the plasma concentration vs. time curve (AUC) after administration of sitagliptin/metformin (50/500 and 50/1000 mg/mg) FDC tablet and co-administration of corresponding doses of sitagliptin and metformin as individual tablets
72 hours post dose
Secondary Outcomes (1)
Peak plasma concentration (Cmax) of sitagliptin and metformin after administration of sitagliptin/metformin (50/500 and 50/1000 mg/mg) FDC tablet and co-administration of corresponding doses of sitagliptin and metformin as individual tablets
72 hours post dose
Study Arms (4)
Treatment A
ACTIVE COMPARATORIndividual Tablets of 50 mg sitagliptin and 500 mg metformin
Treatment B
EXPERIMENTALSitagliptin/metformin 50 mg/500 mg tablet
Treatment C
ACTIVE COMPARATORIndividual Tablets of 50 mg sitagliptin and 1000 mg metformin
Treatment D
EXPERIMENTALsitagliptin/metformin 50 mg/1000 mg tablet
Interventions
A single dose of metformin 500 mg tablets
A single dose of FMI sitagliptin/metformin 50 mg/500 mg FDC tablet
A single dose of FMI sitagliptin/metformin 50 mg/1000 mg FDC tablet
A single dose of metformin 1000 mg tablets
Eligibility Criteria
You may qualify if:
- Female subjects of reproductive potential test negative for pregnancy and agree to use appropriate contraception
- Subject is in good health and is a non-smoker
- Subject is willing to avoid strenuous physical activity during the study
- Subject agrees to refrain from eating grapefruit or grapefruit products during the study
You may not qualify if:
- Subject has a history of neoplastic disease (cancer), stroke, chronic seizures, or major neurological disorder. Subject has a history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, or genitourinary abnormalities or diseases
- Subject consumes excessive amounts of alcohol or caffeinated beverages
- Subject has donated blood, had surgery or participated in another clinical study within the past 4 weeks
- Subject has a history of significant multiple and/or severe allergies to prescription or non-prescription drugs or food
- Subject has a history of hypersensitivity to metformin, sitagliptin, or sitagliptin/Metformin
- Subject is a regular user or past abuser of any illicit drugs
- Subject is unable to refrain from or anticipates the use of any medication, including prescription and non-prescription drugs or herbal remedies during the study.
- Subject is a nursing mother
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Migoya EM, Miller JL, Gutierrez M, Zheng W, Johnson-Levonas AO, Liu Q, Matthews CZ, Wagner JA, Gottesdiener KM. Bioequivalence of sitagliptin/metformin fixed-dose combination tablets and concomitant administration of sitagliptin and metformin in healthy adult subjects: a randomized, open-label, crossover study. Clin Drug Investig. 2010;30(12):855-66. doi: 10.1007/BF03256914.
PMID: 20923244RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Monitor
Merck Sharp & Dohme LLC
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 18, 2009
First Posted
August 19, 2009
Study Start
December 1, 2005
Primary Completion
December 1, 2005
Study Completion
January 1, 2006
Last Updated
November 13, 2019
Record last verified: 2019-11