Status:
COMPLETED
Pharmacokinetic and Pharmacodynamic Drug-Drug Interaction of Evogliptin and Empagliflozin or Dapagliflozin in Healthy Male Adults
Lead Sponsor:
Dong-A ST Co., Ltd.
Conditions:
Type2 Diabetes
Eligibility:
MALE
19-55 years
Phase:
PHASE1
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 ...
Eligibility Criteria
Inclusion
- Health Male Volunteers (Age : 19\~55 years)
- Body Weight≥55kg, 18.5≤BMI\<25.0
Exclusion
- 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
Key Trial Info
Start Date :
November 22 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 18 2019
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT03766724
Start Date
November 22 2018
End Date
January 18 2019
Last Update
April 10 2019
Active Locations (1)
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1
Clinical Trials Center, Severance Hospital
Seoul, South Korea, 03722