Study to Assess the Effect of Food on Combination Dapagliflozin/Metformin Tablet in Healthy Volunteers

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Dapagliflozin/Metformin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01156246

D1691C00005

Details and patient eligibility

About

The purpose of this study is to determine whether treatment with a fixed dose combination dapagliflozin/metformin tablet is affected by food.

Enrollment: 18 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy
• BMI 18-30 kg/m2

Exclusion criteria

• History of clinically significant illness.
• History of alcohol or drug abuse

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

18 participants in 2 patient groups

1

Experimental group

Description:

Dapagliflozin/metformin tablet, high fat, high calorie breakfast day 1, visit 2, 7-14 days wash-out, Dapagliflozin/metformin tablet, fasting conditions day 1, visit 3.

Treatment:

Drug: Dapagliflozin/Metformin

2

Experimental group

Description:

Dapagliflozin/metformin tablet, fasting conditions day 1, visit 2, 7-14 days wash-out, Dapagliflozin/metformin tablet, high fat, high calorie breakfast day 1, visit 3.

Treatment:

Drug: Dapagliflozin/Metformin