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

• Status: Completed
• Trial end date: 2019-01-18
• Target enrollment: 0
• Participant gender: Male

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Dong-A ST Co., Ltd.
• Treatments: Dapagliflozin; Empagliflozin

Criteria

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