Drug Interaction Study of Saxagliptin in Combination With Dapagliflozin in Healthy Participants

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: Dapagliflozin; Drug: Saxagliptin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01662999

CV181-191

Details and patient eligibility

About

The purpose of this study is to evaluate whether the pharmacokinetics (body concentrations/metabolism of the drug) of Saxagliptin and Dapagliflozin are affected when they are administered together

Enrollment: 42 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy subjects as determined by no clinically significant deviation from normal in medical history, Physical Examination, vital signs, 12-lead ECG, and clinical laboratory determinations
• Body mass index (BMI) of 18 to 30 kg/m2
• Men and women, ages 18 to 45 years
• Women of childbearing potential must use acceptable methods of highly effective birth control

Exclusion criteria

• History of chronic or recurrent urinary tract infection for females
• History of allergies or adverse reactions to Dipeptidyl peptidase-IV (DPP4) or Sodium-glucose transporter type 2 (SGLT2) inhibitors
• Any significant acute or chronic medical illness
• Current or recent gastrointestinal disease
• Any major surgery within 4 weeks of study drug administration
• Prior exposure to saxagliptin or dapagliflozin or related drugs

Trial design

42 participants in 6 patient groups

A-B-C: Saxagliptin-Dapagliflozin-(Saxagliptin+Dapagliflozin)

Experimental group

Description:

Treatment A: Saxagliptin 5mg, Tablet, Oral; Single dose Treatment B: Dapagliflozin 10mg, Tablet, Oral; single dose Treatment C: Saxagliptin 5 mg + Dapagliflozin 10 mg, Tablets, Oral; single dose

Treatment:

Drug: Saxagliptin

Drug: Dapagliflozin

A-C-B: Saxagliptin-(Saxagliptin+Dapagliflozin)-Dapagliflozin

Experimental group

Description:

Treatment A: Saxagliptin 5mg, Tablet, Oral, single dose; Treatment C: Saxagliptin 5 mg + Dapagliflozin 10 mg, Tablets, Oral, single dose; Treatment B: Dapagliflozin 10mg, Tablet, Oral, single dose

Treatment:

Drug: Saxagliptin

Drug: Dapagliflozin

B-A-C: Dapagliflozin-Saxagliptin-(Saxagliptin+Dapagliflozin)

Experimental group

Description:

Treatment B: Dapagliflozin 10mg, Tablet, Oral, single dose. Treatment A: Saxagliptin 5mg, Tablet, Oral, single dose; Treatment C: Saxagliptin 5 mg + Dapagliflozin 10 mg, Tablets, Oral, single dose

Treatment:

Drug: Saxagliptin

Drug: Dapagliflozin

B-C-A: Dapagliflozin-(Saxagliptin+Dapagliflozin)-Saxagliptin

Experimental group

Description:

Treatment B: Dapagliflozin 10mg, Tablet, Oral, single dose; Treatment C: Saxagliptin 5 mg + Dapagliflozin 10 mg, Tablets, Oral, single dose; Treatment A: Saxagliptin 5mg, Tablet, Oral, single dose

Treatment:

Drug: Saxagliptin

Drug: Dapagliflozin

C-A-B: (Saxagliptin+Dapagliflozin)-Saxagliptin-Dapagliflozin

Experimental group

Description:

Treatment C: Saxagliptin 5 mg + Dapagliflozin 10 mg, Tablets, Oral, single dose; Treatment A: Saxagliptin 5mg, Tablet, Oral, single dose; Treatment B: Dapagliflozin 10mg, Tablet, Oral, single dose

Treatment:

Drug: Saxagliptin

Drug: Dapagliflozin

C-B-A: (Saxagliptin+Dapagliflozin)-Dapagliflozin-Saxagliptin

Experimental group

Description:

Treatment C: Saxagliptin 5 mg + Dapagliflozin 10 mg, Tablets, Oral, single dose; Treatment B: Dapagliflozin 10mg, Tablet, Oral, Once daily, single dose; Treatment A: Saxagliptin 5mg, Tablet, Oral, single dose

Treatment:

Drug: Saxagliptin

Drug: Dapagliflozin