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
Overview
- Phase
- Phase 1
- Intervention
- Evogliptin→Evogliptin+Dapagliflozin→Dapagliflozin
- Conditions
- Type2 Diabetes
- Sponsor
- Dong-A ST Co., Ltd.
- Enrollment
- 42
- Locations
- 1
- Primary Endpoint
- AUCτ,ss
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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
Investigators
Eligibility 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
Arms & Interventions
Group C
Evogliptin→Evogliptin+Dapagliflozin→Dapagliflozin
Intervention: Evogliptin→Evogliptin+Dapagliflozin→Dapagliflozin
Group A
Evogliptin→Evogliptin+Empagliflozin→Empagliflozin
Intervention: Evogliptin→Evogliptin+Empagliflozin→Empagliflozin
Group B
Empagliflozin→Evogliptin→Evogliptin+Empagliflozin
Intervention: Empagliflozin→Evogliptin→Evogliptin+Empagliflozin
Group D
Dapagliflozin→Evogliptin→Evogliptin+Dapagliflozin
Intervention: Dapagliflozin→Evogliptin→Evogliptin+Dapagliflozin
Outcomes
Primary Outcomes
AUCτ,ss
Time Frame: 4 weeks
area under the concentration-time curve
Cmax,ss
Time Frame: 4 weeks
maximum serum concentration