Bioequivalence Study of 2.5-mg Saxagliptin and 500-mg Glucophage in Tablets and a Fixed-dose Combination Tablet in Healthy Participants

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT01068717
• Date of registration: 12/02/2010
• Prospective Registration: Yes
• Primary sponsor: AstraZeneca
• Public title: Bioequivalence Study of 2.5-mg Saxagliptin and 500-mg Glucophage in Tablets and a Fixed-dose Combination Tablet in Healthy Participants
• Scientific 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
• Date of first enrolment: March 2010
• Target sample size: 27
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01068717
• Study type: Interventional
• Phase: Phase 1

Countries of recruitment

United States

Contacts

• Name: Bristol-Myers Squibb
• Affiliation: Bristol-Myers Squibb

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 55 Years
Gender: All

Health Condition(s) or Problem(s) studied

Type 2 Diabetes Mellitus

Intervention(s)

Drug: Saxagliptin, 2.5 mg + Metformin, 500 mg (fed state)

Drug: Saxagliptin, 2.5 mg /Metformin, 500 mg FDC (fed state)

Drug: Saxagliptin, 2.5 mg /Metformin, 500 mg FDC (fasted state)

Drug: Saxagliptin, 2.5 mg + Metformin, 500 mg (fasted state)

Primary Outcome(s)

Terminal Half-life (t1/2) of Saxagliptin and Metformin, Tablets and FDC, Administered to Participants in the Fasted and Fed States [Time Frame: Days 1, 2, and 3 of Periods 1, 2, 3, and 4]

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 [Time Frame: Days 1, 2, and 3 of Periods 1, 2, 3, and 4]

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 [Time Frame: Days 1, 2, and 3 of Periods 1, 2, 3, and 4]

AUC From Time 0 Extrapolated to Infinity (AUC[0-inf]) for Saxagliptin, Tablets and FDC, Given in the Fasted and Fed States [Time Frame: Days 1, 2, and 3 of Periods 1, 2, 3, and 4]

AUC[0-inf] for Metformin, Tablets and FDC, Administered in the Fasted and Fed States [Time Frame: Days 1, 2, and 3 of Periods 1, 2, 3, and 4]

AUC[0-t] for Metformin, Tablets and FDC, Given in the Fasted and Fed States [Time Frame: Days 1, 2, and 3 of Periods 1, 2, 3, and 4]

Observed Maximum Plasma Concentration (Cmax) of Saxagliptin, Tablets and Fixed-dose Combination (FDC), Administered to Participants in the Fasted and Fed States [Time Frame: Days 1, 2, and 3 of Periods 1, 2, 3, and 4]

Observed Cmax of Metformin, Tablets and FDC, Administered to Participants in the Fasted and Fed States [Time Frame: Days 1, 2, and 3 of Periods 1, 2, 3, and 4]

Secondary Outcome(s)

Number of Participants With Death as Outcome, Serious Adverse Events, and Adverse Events (AEs) Leading to Discontinuation [Time Frame: Continuously over Days 1 to 3 of treatment Periods 1, 2, 3, and 4]

Number of Participants With Clinically Significant Abnormalities in Electrocardiogram (ECG) Results [Time Frame: At screening visit, Day -1 of Period 1, and at study discharge]

Number of Participants With Clinically Significant Abnormalities in Body Temperature, Blood Pressure, or Heart Rate [Time Frame: At screening visit, prior to dosing on Day 1 of Periods 1 through 4, and at study discharge.]

Number of Participants With Clinically Significant Abnormalities in Hematology, Serum Chemistry, and Urinalysis Laboratory Test Results [Time Frame: At screening visit, at Day -1 of Periods 1 through 4, and at discharge]

Secondary ID(s)

CV181-118

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 21/10/2011
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01068717