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

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: Saxagliptin, 2.5 mg /Metformin, 500 mg FDC (fasted state); Drug: Saxagliptin, 2.5 mg /Metformin, 500 mg FDC (fed state); Drug: Saxagliptin, 2.5 mg + Metformin, 500 mg (fasted state); Drug: Saxagliptin, 2.5 mg + Metformin, 500 mg (fed state)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01068717

CV181-118

Details and patient eligibility

About

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.

Enrollment: 27 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

27 participants in 4 patient groups

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

Other group

Description:

Single oral doses of saxagliptin, 2.5 mg, and metformin, 500 mg, administered together as tablets in the fasted state

Treatment:

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

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

Other group

Description:

Single oral dose of a 2.5-mg saxagliptin/500-mg metformin fixed-dose combination (FDC) tablet administered in the fasted state

Treatment:

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

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

Other group

Description:

Single oral doses of saxagliptin, 2.5 mg, and metformin, 500 mg, administered together as tablets in the fed state

Treatment:

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

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

Other group

Description:

Single oral dose of saxagliptin, 2.5 mg/metformin, 500 mg, FDC tablet administered in the fed state

Treatment:

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