Drug Interaction With Metformin

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Healthy Male and Female Subjects

Treatments: Drug: Metformin; Drug: Dapagliflozin + Metformin; Drug: Dapagliflozin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00546741

MB102-026

Details and patient eligibility

About

The purpose of the study is to determine the effect of metformin on dapagliflozin exposure and the effect of dapagliflozin on metformin exposure in healthy volunteers. Additionally, the safety and tolerability of dapagliflozin will be assessed in the presence and absence of metformin in healthy volunteers

Enrollment: 18 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy men and women, ages 18-45 with a body mass index of 18-32 kg/m2

Exclusion criteria

• Unwilling to use acceptable method of birth control
• current or recent (within 1 month) smoker
• abnormal liver function tests
• presence of edema
• history of diabetes mellitus
• history of heart failure or renal insufficiency
• history of chronic or recurrent urinary tract infections, or vulvovaginal mycotic infections
• history of Hepatitis C

Trial design

18 participants in 3 patient groups

1

Experimental group

Treatment:

Drug: Dapagliflozin

2

Active Comparator group

Treatment:

Drug: Metformin

3

Active Comparator group

Treatment:

Drug: Dapagliflozin + Metformin