A Clinical Trial to Investigate Safety/Tolerability and Pharmacokinetics of DA-1229_01 Compared to Co-administration of Evogliptin 5 mg and Metformin XR 1000 mg, and to Evaluate the Effect of Food on the Pharmacokinetics of DA-1229_01 in Healthy Male Volunteers
Phase 1
Completed
- Conditions
- Type 2 Diabetes Mellitus
- Interventions
- Registration Number
- NCT02167061
- Lead Sponsor
- Dong-A ST Co., Ltd.
- Brief Summary
This Phase I clinical study is to evaluate the safety/tolerability and pharmacokinetics of DA-1229_01 and to investigate the effect of food on the pharmacokinetics of DA-1229_01 in healthy male volunteers
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 64
Inclusion Criteria
- Age between 20 to 45, healthy male subjects(at screening)
- Body weight between 55kg - 90kg, BMI between 18.0 - 27.0
- FPG 60-125mg/dL glucose level(at screening)
- Volunteer who totally understands the progress of this clinical trials, make decision by his free will, and signed a consent form to follow the progress.
Exclusion Criteria
- Volunteer who has past or present history of any diseases following below.(liver including hepatitis virus carrier, kidney, Neurology, immunology, pulmonary, endocrine, hematooncology, cardiology, mental disorder)
- Volunteer who had GI tract disease(Crohn's disease, ulcer, acute or chronic pancreatitis) or surgery(appendectomy, hernioplasty are excluded)
- Volunteer who had drug(Aspirin, antibiotics) hypersensitivity reaction
- Subject who already participated in other trials in 2 months
- Subject who had whole blood donation in 2 months, or component blood donation in 1 months or transfusion
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description (Part 2) DA-1229_01 fast → fed DA-1229_01 fed DA-1229_01 : Evogliptin/Metformin XR 5/1000mg Fast : administration on an empty stomach Fed: administration after high-fat diet (Part 2) DA-1229_01 fast → fed DA-1229_01 fast DA-1229_01 : Evogliptin/Metformin XR 5/1000mg Fast : administration on an empty stomach Fed: administration after high-fat diet (Part 1) DA-1229_01 → E+M E+M DA-1229_01 : Evogliptin/Metformin XR 5/1000mg E : Evogliptin 5 mg M : Metformin XR 1000 mg (Part 1) E+M → DA-1229_01 E+M DA-1229_01 : Evogliptin/Metformin XR 5/1000mg E : Evogliptin 5 mg M : Metformin XR 1000 mg DA-1229_01 fed → fast DA-1229_01 fast DA-1229_01 : Evogliptin/Metformin XR 5/1000mg Fast : administration on an empty stomach Fed: administration after high-fat diet DA-1229_01 fed → fast DA-1229_01 fed DA-1229_01 : Evogliptin/Metformin XR 5/1000mg Fast : administration on an empty stomach Fed: administration after high-fat diet (Part 1) DA-1229_01 → E+M DA-1229_01 DA-1229_01 : Evogliptin/Metformin XR 5/1000mg E : Evogliptin 5 mg M : Metformin XR 1000 mg (Part 1) E+M → DA-1229_01 DA-1229_01 DA-1229_01 : Evogliptin/Metformin XR 5/1000mg E : Evogliptin 5 mg M : Metformin XR 1000 mg
- Primary Outcome Measures
Name Time Method Maximum of concentration (Cmax) of Evogliptin and Metformin 1d(15d) pre-dose, 1,2,3,4,5,6,7,8,10,12,15,24,36,48,60,72h post-dose Area Under Curve(AUC)last of Evogliptin and Metformin 1d(15d) pre-dose, 1,2,3,4,5,6,7,8,10,12,15,24,36,48,60,72h post-dose
- Secondary Outcome Measures
Name Time Method Area Under Curve(AUC)inf of Evogliptin and Metformin 1d(15d) pre-dose, 1,2,3,4,5,6,7,8,10,12,15,24,36,48,60,72h post-dose AUCinf = AUC last + Clast/λz
Time prior to the first measurable concentration (tlag) of Metformin (only in Part 2 trial) 1d(15d) pre-dose, 1,2,3,4,5,6,7,8,10,12,15,24,36,48,60,72h post-dose Apparent Clearance(CL/F) of Evogliptin and Metformin 1d(15d) pre-dose, 1,2,3,4,5,6,7,8,10,12,15,24,36,48,60,72h post-dose Time of maximum concentration(Tmax) of Evogliptin and Metformin 1d(15d) pre-dose, 1,2,3,4,5,6,7,8,10,12,15,24,36,48,60,72h post-dose Terminal half-life(t1/2) of Evogliptin and Metformin 1d(15d) pre-dose, 1,2,3,4,5,6,7,8,10,12,15,24,36,48,60,72h post-dose
Trial Locations
- Locations (1)
Clinical Trial Center, Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of