Drug Interaction With Metformin

AstraZeneca18 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

NONE

Enrollment

Conditions

Healthy Male and Female Subjects

Interventions

DapagliflozinDRUG

Tablets, Oral, 20 mg, once daily single dose

MetforminDRUG

Tablets, Oral, 1000 mg, once daily, single dose

Dapagliflozin + MetforminDRUG

Tablets, Oral, once daily, single dose Dapagliflozin: 20 mg Metformin: 1000 mg

Eligibility

Sex: ALLMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Bristol-Myers Squibb Clinical Pharmacology Unit

Hamilton, New Jersey, United States

Outcomes

Primary Outcomes

To determine the effect of metformin on the exposure of dapagliflozin and the effect of dapagliflozin on the exposure of metformin in healthy subjects after a single dose of each treatment

Time frame: measures taken daily throughout the study

Secondary Outcomes

To assess the safety and tolerability of dapagliflozin when administered alone or with metformin after a single dose of each treatment

Time frame: measures will be taken at the beginning and end of the study, as well as 1 time every 3 days (Day -1 of each study period)

Data from ClinicalTrials.gov

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