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Pharmacokinetic and Pharmacodynamic Drug-Drug Interaction of Evogliptin and Empagliflozin or Dapagliflozin in Healthy Male Adults

NCT03766724 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2019-04-10

No results posted yet for this study

Summary

A Randomized, Open-label, Multiple-dose, Crossover Study to Investigate the Pharmacokinetic and Pharmacodynamic Drug-Drug Interaction of Evogliptin 5 mg and Empagliflozin 25 mg or Dapagliflozin 10 mg after Oral Administration in Healthy Male Adults

Conditions

  • Type2 Diabetes

Interventions

DRUG

Evogliptin→Evogliptin+Empagliflozin→Empagliflozin

Evogliptin : Evogliptin 5mg QD, Evogliptin+Empagliflozin : Evogliptin 5mg QD + Empagliflozin 25mg QD, Empagliflozin : Empagliflozin 25mg QD

DRUG

Empagliflozin→Evogliptin→Evogliptin+Empagliflozin

Empagliflozin : Empagliflozin 25mg QD, Evogliptin : Evogliptin 5mg QD, Evogliptin+Empagliflozin : Evogliptin 5mg QD + Empagliflozin 25mg QD

DRUG

Evogliptin→Evogliptin+Dapagliflozin→Dapagliflozin

Evogliptin : Evogliptin 5mg QD, Evogliptin+Dapagliflozin : Evogliptin 5mg QD + Dapagliflozin 10mg QD, Dapagliflozin : Dapagliflozin 10mg QD

DRUG

Dapagliflozin→Evogliptin→Evogliptin+Dapagliflozin

Dapagliflozin : Dapagliflozin 10mg QD, Evogliptin : Evogliptin 5mg QD, Evogliptin+Dapagliflozin : Evogliptin 5mg QD + Dapagliflozin 10mg QD

Sponsors & Collaborators

  • Dong-A ST Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Min soo Park, M.D., Ph.D. · Clinical Trial Center, Severance Hospital

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
19 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-11-22
Primary Completion
2019-01-18
Completion
2019-01-18

Countries

  • South Korea

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 NCT03766724 on ClinicalTrials.gov