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

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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03766724
Enrollment
42
Registered
2018-12-06
Start date
2018-11-22
Completion date
2019-01-18
Last updated
2019-04-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type2 Diabetes

Brief 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

Interventions

DRUGEvogliptin→Evogliptin+Empagliflozin→Empagliflozin

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

DRUGEmpagliflozin→Evogliptin→Evogliptin+Empagliflozin

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

DRUGEvogliptin→Evogliptin+Dapagliflozin→Dapagliflozin

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

DRUGDapagliflozin→Evogliptin→Evogliptin+Dapagliflozin

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

Sponsors

Dong-A ST Co., Ltd.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
19 Years to 55 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Cmax,ss4 weeksmaximum serum concentration
AUCτ,ss4 weeksarea under the concentration-time curve

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026