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Bexagliflozin Drug/Drug Interaction Study With Digoxin

NCT03197324 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2021-07-23

Study results available
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Summary

The purpose of this study is to examine the drug-drug interaction in your body when given the study drug, bexagliflozin, with the heart failure medication digoxin. The study will evaluate whether bexagliflozin effects the amount of digoxin in your blood and how safe the study drug is and how well the study drug is tolerated when taken with digoxin.

Conditions

  • Type2 Diabetes Mellitus

Interventions

DRUG

Bexagliflozin

Bexagliflozin tablets, 20 mg

DRUG

Digoxin

2 0.25 mg Digoxin tablets (total dose 0.5 mg digoxin)

Sponsors & Collaborators

  • Theracos

    lead INDUSTRY

Principal Investigators

  • Mason Freeman, M.D. · Massachusetts General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-07-24
Primary Completion
2017-09-17
Completion
2017-09-17
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03197324 on ClinicalTrials.gov