Pharmacokinetic Drug Interaction Study With Dapagliflozin and Glimepiride in Healthy Subjects

AstraZeneca11 enrolled

Overview

The purpose of the study is to determine the effect of glimepiride on dapagliflozin and the effect of dapagliflozin on glimepiride in healthy volunteers. In addition, the safety and tolerability of dapagliflozin with be assessed alone and while taking glimepiride

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Diabetes Mellitus, Type 2

Interventions

DapagliflozinDRUG

Tablets, Oral, 20 mg, once daily, single dose

GlimepirideDRUG

Tablets, Oral, 4 mg, once daily, single dose

Dapagliflozin + GlimepirideDRUG

Tablets, Oral, Dapagliflozin 20 mg + Glimepiride 4 mg, once daily, single dose

Eligibility

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

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy subjects with BMI of 18-32 kg/m2 Exclusion Criteria: * Abnormal physical or lab findings * Allergies to any sulfonylurea or related compounds

Locations (1)

Local Institution

Vicente López, Buenos Aires, Argentina

Outcomes

Primary Outcomes

Maximum plasma concentration and exposure to glimepiride and dapagliflozin when administered alone and administered together

Time frame: plasma concentrations will be measures as specified timepoints for 72 hours after each administred dose

Secondary Outcomes

Measures of the plasma concentration of the active metabolite of glimepiride when administered alone or coadministered with glimepiride

Time frame: for 72 hours after each administered dose

Recorded adverse events

Time frame: for 72 hours after each administered dose

Data from ClinicalTrials.gov

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