Bioequivalence/Food Effect - Saxa/Dapa Dual Fixed Dose Combination (FDC)

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: Saxagliptin/Dapagliflozin FDC; Drug: Dapagliflozin; Drug: Saxagliptin

Study type: Interventional

Funder types: Industry

Identifiers

NCT02060201

CV181-341

118,840 (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to demonstrate the bioequivalence (BE) of Saxagliptin and Dapagliflozin from a 2.5-mg Saxagliptin/5-mg Dapagliflozin FDC tablet after oral administration relative to 2.5-mg Saxagliptin and 5-mg Dapagliflozin tablets administered orally together in the fasted state and to demonstrate the BE of Saxagliptin and Dapagliflozin from a 5-mg Saxagliptin/10-mg Dapagliflozin FDC tablet after oral administration relative to 5-mg Saxagliptin and 10-mg Dapagliflozin tablets administered orally together in the fasted state. Demonstrating bioequivalence refers to showing that the FDC tablet and co-administration of the individual components yield similar blood levels/concentrations of the drug and are handled by the body similarly.

Full description

Primary Purpose: This study is designed to demonstrate the bioequivalence of Saxagliptin and Dapagliflozin from a FDC tablet after oral administration relative to Saxagliptin and Dapagliflozin tablets administered orally together in the fasted and fed state

Enrollment: 72 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

• Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination (PE), vital signs, 12-lead ECG, and clinical laboratory determinations
• Body mass index (BMI) of 18.5 to 30 kg/m(2)
• Men and women, ages 18 to 50 years
• Women of childbearing potential must use acceptable methods of highly effective birth control

Exclusion Criteria:

• Any significant acute or chronic medical illness
• Current or recent gastrointestinal disease
• Any major surgery within 4 weeks of study drug administration
• History of chronic or recurrent urinary tract infection for females
• History of glucose intolerance or diabetes mellitus
• History of allergies or adverse reactions to Dipeptidyl peptidase-IV (DPP4) or Sodium-glucose cotransporter (SGLT) inhibitors
• Prior exposure to Saxagliptin or Dapagliflozin or related drugs

Trial design

72 participants in 6 patient groups

Treatment A: Saxagliptin 2.5mg+Dapagliflozin 5mg; Fasting

Other group

Description:

Saxagliptin 2.5 mg tablet and Dapagliflozin 5 mg tablet single dose orally on Day 1 in one of 3 periods

Treatment:

Drug: Saxagliptin

Drug: Dapagliflozin

Treatment B: Saxagliptin 2.5mg/Dapagliflozin 5mg FDC; Fasting

Other group

Description:

Saxagliptin 2.5 mg/Dapagliflozin 5 mg fixed dose combination tablet single dose orally on Day 1 in one of 3 periods

Treatment:

Drug: Saxagliptin/Dapagliflozin FDC

Treatment C: Saxagliptin 2.5mg/Dapagliflozin 5mg FDC; Fed

Other group

Description:

Saxagliptin 2.5 mg/Dapagliflozin 5 mg fixed dose combination tablet single dose orally on Day 1 in one of 3 periods

Treatment:

Drug: Saxagliptin/Dapagliflozin FDC

Treatment D: Saxagliptin 5mg+Dapagliflozin 10mg; Fasting

Other group

Description:

Saxagliptin 5 mg tablet and Dapagliflozin 10 mg tablet single dose orally for on Day 1 in one of 3 periods

Treatment:

Drug: Saxagliptin

Drug: Dapagliflozin

Treatment E: Saxagliptin 5mg/Dapagliflozin 10mg FDC; Fasting

Other group

Description:

Saxagliptin 5 mg/Dapagliflozin 10 mg fixed dose combination tablet single dose orally on Day 1 in one of 3 periods

Treatment:

Drug: Saxagliptin/Dapagliflozin FDC

Treatment F: Saxagliptin 5mg/Dapagliflozin 10mg FDC; Fed

Other group

Description:

Saxagliptin 5 mg/Dapagliflozin 10 mg fixed dose combination tablet single dose orally on Day 1 in one of 3 periods

Treatment:

Drug: Saxagliptin/Dapagliflozin FDC