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Bioequivalence Study of Fixed Dose Combination of 2.5 mg Saxagliptin/850 mg Metformin Tablet Relative to 2.5 mg Onglyza and 850 mg Glucophage Tablets Co-Administered

Information source: AstraZeneca
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Type 2 Diabetes Mellitus

Intervention: saxagliptin (Drug); metformin (Drug); saxagliptin + metformin (FDC tablet) (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
Bristol-Myers Squibb, Study Director, Affiliation: Bristol-Myers Squibb


To demonstrate bioequivalence of a 2. 5 mg saxagliptin/850 mg metformin fixed dose combination (FDC) tablet relative to the 2. 5 mg saxagliptin tablet and 850 mg metformin (Glucophage Marketed by Merck-Serono) tablet co-administered to healthy subjects in the fasted and fed condition.

Clinical Details

Official title: Bioequivalence Study of the Fixed Dose Combination of 2.5 mg Saxagliptin and 850 mg Metformin Tablet Relative to a 2.5 mg Saxagliptin (Onglyza) Tablet and a 850 mg Metformin (Glucophage Marketed by Merck Serono) Tablet Co-Administered to Healthy Subjects in the Fasted and Fed Conditions

Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label

Primary outcome:

Saxagliptin Pharmacokinetic (PK) Parameter Area Under the Plasma Concentration Versus Time Curve From Time 0 Extrapolated to Infinity (AUC[0-inf])

Saxagliptin PK Parameter Observed Maximum Plasma Concentration (Cmax)

Metformin PK Parameter AUC(0-inf)

Metformin PK Parameter Cmax

Secondary outcome:

5-hydroxy Saxagliptin PK Parameter AUC(0-inf)

5-hydroxy Saxagliptin PK Parameter Cmax

5-hydroxy Saxagliptin PK Parameter Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC[0-t])

5-hydroxy Saxagliptin PK Parameter Terminal Half-life (T 1/2)

5-hydroxy Saxagliptin PK Parameter Time to Achieve the Observed Maximum Plasma Concentration (Tmax)

Safety: Adverse Events (AEs), Discontinuations Due to AEs, Deaths, and Serious AEs (SAEs).

Safety: Clinically Significant Laboratory, Vital Sign, Physical Examination, and/or 12-Lead Electrocardiogram (ECG) Abnormalities


Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Both.


Inclusion Criteria:

- Men and women ages 18 to 55 inclusive

- Healthy subjects as determined by no clinically significant deviation from normal in

medical history, physical examination, electrocardiograms (ECGs), and clinical laboratory determinations

- Body Mass Index (BMI) of 18 to 32 kg/m^2, inclusive. BMI = weight (kg)/ [height

(m)]^2 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 a dipeptidyl peptidase-IV (DPP4) inhibitor or related compound

- History of allergy or intolerance to metformin or other similar acting agents

- Prior exposure to saxagliptin

- Prior exposure to metformin within 3 months of study drug administration

- Estimated creatinine clearance (Clcr) of < 80 mL/min using the Cockcroft Gault


Locations and Contacts

PPD Development, LP, Austin, Texas 78744, United States
Additional Information

BMS Clinical Trials Disclosure

Investigator Inquiry form

For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm

Starting date: February 2010
Last updated: April 21, 2015

Page last updated: August 23, 2015

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