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

NCT03766724 | Completed Phase 1

• 1 other identifier: DA1229_DIS_I
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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

Conditions

Type2 Diabetes

Outcome Measures

Primary Outcomes (2)

• AUCτ,ss

  area under the concentration-time curve

  4 weeks

• Cmax,ss

  maximum serum concentration

  4 weeks

Study Arms (4)

Group A

EXPERIMENTAL

Evogliptin→Evogliptin+Empagliflozin→Empagliflozin

Drug: Evogliptin→Evogliptin+Empagliflozin→Empagliflozin

Group B

EXPERIMENTAL

Empagliflozin→Evogliptin→Evogliptin+Empagliflozin

Drug: Empagliflozin→Evogliptin→Evogliptin+Empagliflozin

Group C

EXPERIMENTAL

Evogliptin→Evogliptin+Dapagliflozin→Dapagliflozin

Drug: Evogliptin→Evogliptin+Dapagliflozin→Dapagliflozin

Group D

EXPERIMENTAL

Dapagliflozin→Evogliptin→Evogliptin+Dapagliflozin

Drug: Dapagliflozin→Evogliptin→Evogliptin+Dapagliflozin

Interventions

Evogliptin→Evogliptin+Empagliflozin→Empagliflozin DRUG

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

Also known as: Suganon, Jardiance

Group A

Empagliflozin→Evogliptin→Evogliptin+Empagliflozin DRUG

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

Also known as: Suganon, Jardiance

Group B

Evogliptin→Evogliptin+Dapagliflozin→Dapagliflozin DRUG

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

Also known as: Suganon, Forxiga

Group C

Dapagliflozin→Evogliptin→Evogliptin+Dapagliflozin DRUG

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

Also known as: Suganon, Forxiga

Group D

Eligibility Criteria

• Age: 19 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dong-A ST Co., Ltd.: lead

Study Sites (1)

Clinical Trials Center, Severance Hospital

Seoul, 03722, South Korea

Location

MeSH Terms

Interventions

empagliflozin; dapagliflozin

Study Officials

• Min soo Park, M.D., Ph.D.

  Clinical Trial Center, Severance Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2018
• First Posted: December 6, 2018
• Study Start: November 22, 2018
• Primary Completion: January 18, 2019
• Study Completion: January 18, 2019
• Last Updated: April 10, 2019

Record last verified: 2019-04

Locations

KR (1)