Clinical trial NCT01068717: Bioequivalence Study of 2.5-mg Saxagliptin and 500-mg Glucophage in Tablets and a Fixed-dose Combination Tablet in Healthy Participants
Official title: Bioequivalence Study of the Fixed Dose Combination of 2.5 mg Saxagliptin and 500 mg Metformin Tablet Relative to a 2.5 mg Saxagliptin (Onglyza) Tablet and a 500 mg Metformin (Glucophage Marketed in Canada by Sanofi-Aventis) Tablet Co-Administered to Healthy Subjects in the Fasted and Fed States
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2010-02-15
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: To demonstrate the bioequivalence of a 2.5-mg saxagliptin/500-mg metformin fixed-dose combination (FDC) tablet to that of 2.5-mg saxagliptin (Onglyza) and 500-mg metformin (Glucophage, marketed in Canada by Sanofi-Aventis) tablets coadministered to healthy participants in the fasted and fed states.


Eligibility criteria: Inclusion Criteria:

* Men and women, aged 18 to 55 years, inclusive
* Healthy participants as determined by a lack of clinically significant deviation from normal in medical history, physical examination, electrocardiograms, and clinical laboratory determinations
* Body Mass Index of 18 to 32 kg/m\^2, inclusive

Exclusion Criteria:

* Any significant acute or chronic medical illness
* Current or recent (within 3 months) gastrointestinal disease
* Any major surgery within 4 weeks of study drug administration
* History of allergy to DPP-4 inhibitors or related compounds
* History of allergy or intolerance to metformin or other similar acting agents
* Previous exposure to saxagliptin
* Exposure to metformin within 3 months pervious to study drug administration
* Estimated creatinine clearance of \<80 mL/min using the Cockcroft Gault formula

Primary outcomes:
measure: Observed Maximum Plasma Concentration (Cmax) of Saxagliptin, Tablets and Fixed-dose Combination (FDC), Administered to Participants in the Fasted and Fed States
timeFrame: Days 1, 2, and 3 of Periods 1, 2, 3, and 4
measure: Observed Cmax of Metformin, Tablets and FDC, Administered to Participants in the Fasted and Fed States
timeFrame: Days 1, 2, and 3 of Periods 1, 2, 3, and 4
measure: Terminal Half-life (t1/2) of Saxagliptin and Metformin, Tablets and FDC, Administered to Participants in the Fasted and Fed States
timeFrame: Days 1, 2, and 3 of Periods 1, 2, 3, and 4
measure: Area Under the Plasma Concentration-time Curve From Time 0 to the Last Quantifiable Concentration (AUC[0-t]) for Saxagliptin, Tablets and FDC, Given in the Fasted and Fed States
timeFrame: Days 1, 2, and 3 of Periods 1, 2, 3, and 4
measure: AUC[0-t] for Metformin, Tablets and FDC, Given in the Fasted and Fed States
timeFrame: Days 1, 2, and 3 of Periods 1, 2, 3, and 4
measure: AUC From Time 0 Extrapolated to Infinity (AUC[0-inf]) for Saxagliptin, Tablets and FDC, Given in the Fasted and Fed States
timeFrame: Days 1, 2, and 3 of Periods 1, 2, 3, and 4
measure: AUC[0-inf] for Metformin, Tablets and FDC, Administered in the Fasted and Fed States
timeFrame: Days 1, 2, and 3 of Periods 1, 2, 3, and 4
measure: Time to Achieve the Observed Maximum Plasma Concentration (Tmax) for Saxagliptin and Metformin, Tablets and FDC, Administered to Participants in the Fasted and Fed States
timeFrame: Days 1, 2, and 3 of Periods 1, 2, 3, and 4
Secondary outcomes:
measure: Number of Participants With Death as Outcome, Serious Adverse Events, and Adverse Events (AEs) Leading to Discontinuation
timeFrame: Continuously over Days 1 to 3 of treatment Periods 1, 2, 3, and 4
measure: Number of Participants With Clinically Significant Abnormalities in Hematology, Serum Chemistry, and Urinalysis Laboratory Test Results
timeFrame: At screening visit, at Day -1 of Periods 1 through 4, and at discharge
measure: Number of Participants With Clinically Significant Abnormalities in Electrocardiogram (ECG) Results
timeFrame: At screening visit, Day -1 of Period 1, and at study discharge
measure: Number of Participants With Clinically Significant Abnormalities in Body Temperature, Blood Pressure, or Heart Rate
timeFrame: At screening visit, prior to dosing on Day 1 of Periods 1 through 4, and at study discharge.
Other outcomes:
Locations:
city: Austin
country: United States
facility: Ppd Development, Lp
state: Texas
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: