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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-22

Study Completion Date

2019-01-18

Brief Summary

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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

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Detailed Description

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Conditions

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Type2 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Group A

Evogliptin→Evogliptin+Empagliflozin→Empagliflozin

Group Type EXPERIMENTAL

Evogliptin→Evogliptin+Empagliflozin→Empagliflozin

Intervention Type DRUG

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

Group B

Empagliflozin→Evogliptin→Evogliptin+Empagliflozin

Group Type EXPERIMENTAL

Empagliflozin→Evogliptin→Evogliptin+Empagliflozin

Intervention Type DRUG

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

Group C

Evogliptin→Evogliptin+Dapagliflozin→Dapagliflozin

Group Type EXPERIMENTAL

Evogliptin→Evogliptin+Dapagliflozin→Dapagliflozin

Intervention Type DRUG

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

Group D

Dapagliflozin→Evogliptin→Evogliptin+Dapagliflozin

Group Type EXPERIMENTAL

Dapagliflozin→Evogliptin→Evogliptin+Dapagliflozin

Intervention Type DRUG

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

Interventions

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Evogliptin→Evogliptin+Empagliflozin→Empagliflozin

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

Intervention Type DRUG

Empagliflozin→Evogliptin→Evogliptin+Empagliflozin

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

Intervention Type DRUG

Evogliptin→Evogliptin+Dapagliflozin→Dapagliflozin

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

Intervention Type DRUG

Dapagliflozin→Evogliptin→Evogliptin+Dapagliflozin

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

Intervention Type DRUG

Other Intervention Names

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Suganon Jardiance Suganon Jardiance Suganon Forxiga Suganon Forxiga

Eligibility Criteria

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Inclusion Criteria

* Health Male Volunteers (Age : 19\~55 years)
* Body Weight≥55kg, 18.5≤BMI\<25.0

Exclusion Criteria

* galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption
* Allergy or Drug hypersensitivity
* Clinically significant Medical History
* AST, ALT \> Upper Normal Range\*1.25, eGFR\<60mL/min/1.73㎡
* Drink during clinical trial period
* Smoking during clinical trial period
* Grapefruit/Caffeine intake during clinical trial period
* No Contraception

Minimum Eligible Age

19 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes