Pharmacokinetic/Pharmacodynamic Drug-drug Interaction of Evogliptin 5mg and Glimepiride 4mg
Phase 1
Completed
- Conditions
- Type2 Diabetes
- Interventions
- Drug: Evogliptin→Evogliptin+Glimepiride→GlimepirideDrug: Glimepiride→Evogliptin→Evogliptin+Glimepiride
- Registration Number
- NCT02954822
- Lead Sponsor
- Dong-A ST Co., Ltd.
- Brief Summary
A randomized, open-label, multiple dosing, three treatment, three period, two sequence clinical trial to investigate the pharmacokinetic/pharmacodynamic drug-drug interaction of evogliptin 5 mg and glimepiride 4 mg after oral administration in healthy male subjects
- Detailed Description
A randomized, open-label, multiple-dose, three-treatment, three-period, two-sequence, crossover study
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 36
Inclusion Criteria
- Healthy Male Volunteers (Age: 19~45years)
- 55<Body Weight<90, 18<BMI<27
- FPG: 70-125 mg/dL
Exclusion Criteria
- galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption
- Clinically significant Medical History
- Allergy or Drug Hypersensitivity
- AST(SGOT), ALT(SGPT) > Upper Normal Range*1.5, eGFR<80 mL/min
- Drink during clinical trial period
- Smoking during clinical trial period
- Grapefruit/Caffeine intake during clinical trial period
- No Contraception
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description (Group A) Evogliptin→Evogliptin+Glimepiride→Glimepiride Evogliptin→Evogliptin+Glimepiride→Glimepiride (Group B) Glimepiride→Evogliptin→Evogliptin+Glimepiride Glimepiride→Evogliptin→Evogliptin+Glimepiride
- Primary Outcome Measures
Name Time Method AUCτ,ss for Evogliptin and Glimepiride 3 weeks area under the concentration-time curve
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Clinical Trials Center, Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of