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Completed

NCT Number: NCT03766724

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

Completed

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Key information

Conditions

Type2 Diabetes

Age range

19 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Clinical Trials Center, Severance Hospital

Seoul, 03722, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Evogliptin→Evogliptin+Empagliflozin→Empagliflozin

Drug

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

Other names: Suganon, Jardiance

Empagliflozin→Evogliptin→Evogliptin+Empagliflozin

Drug

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

Other names: Suganon, Jardiance

Evogliptin→Evogliptin+Dapagliflozin→Dapagliflozin

Drug

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

Other names: Suganon, Forxiga

Dapagliflozin→Evogliptin→Evogliptin+Dapagliflozin

Drug

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

Other names: Suganon, Forxiga

Primary outcomes

  1. AUCτ,ss

    Time frame: 4 weeks

    area under the concentration-time curve

  2. Cmax,ss

    Time frame: 4 weeks

    maximum serum concentration

Sponsors and collaborators

Lead sponsor

Dong-A ST Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Dec 6, 2018
Registry last updated
Apr 10, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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