Bioequivalence Study of Saxagliptin and Glucophage Combination Formulations in Healthy Subjects (B)

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: Saxagliptin; Drug: Saxagliptin + Metformin IR (FDC); Drug: Metformin IR (glucophage)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00897390

CV181-092

Details and patient eligibility

About

To demonstrate bioequivalence of a 2.5 mg saxagliptin/1000 mg metformin (glucophage) immediate release (IR) fixed dose combination (FDC) tablet to the 2.5 mg saxagliptin tablet and 1000 mg metformin IR tablet co-administered to healthy subjects in a fasted and in a fed state.

Enrollment: 24 patients

Sex: All

Ages: 19 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Men and women ages 19 to 45 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/m2, inclusive. BMI = weight (kg)/ [height (m)]2

Exclusion criteria

• Women of child-bearing potential (WOCBP) who are unwilling or unable to use acceptable barrier methods (condoms and spermicides) to avoid pregnancy for the entire study period and for up to 8 weeks after the last dose of investigational product
• 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 Dipeptidyl peptidase 4 (DPP4) inhibitor or related compounds
• 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 < 80ml/min using the Cockcroft Gault formula

Trial design

24 participants in 4 patient groups

Arm A

Other group

Description:

Co-administration of single oral doses of a 2.5 mg tablet of saxagliptin and a 1000 mg tablet of metformin IR under fasted conditions

Treatment:

Drug: Metformin IR (glucophage)

Drug: Saxagliptin

Arm B

Other group

Description:

Single oral dose of a FDC tablet consisting of 2.5 mg saxagliptin/ 1000 mg metformin IR under fasted conditions

Treatment:

Drug: Saxagliptin + Metformin IR (FDC)

Arm C

Other group

Description:

Co-administration of single oral doses of a 2.5 mg tablet of saxagliptin and a 1000 mg tablet of metformin IR under fed conditions with a standard meal

Treatment:

Drug: Metformin IR (glucophage)

Drug: Saxagliptin

Arm D

Other group

Description:

Single oral dose of a FDC tablet consisting of 2.5 mg saxagliptin/ 1000 mg metformin IR under fed conditions with a standard meal

Treatment:

Drug: Saxagliptin + Metformin IR (FDC)