Clinical trial NCT02167061: 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
Official title: A Randomized, Open-label, Crossover, Single Dose Clinical Trial to Investigate Safety/Tolerability and Pharmacokinetics of DA-1229_01(Evogliptin/Metformin XR 5/1000 mg) Compared to Co-administration of Evogliptin 5 mg and Metformin XR 1000mg, and to Evaluate the Effect of Food on the Pharmacokinetics of DA-1229_01 After Single Oral Administration in Healthy Male Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Dong-A ST Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2014-06-18
Enrollment: 64
Sex: MALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Area Under Curve(AUC)last of Evogliptin and Metformin
timeFrame: 1d(15d) pre-dose, 1,2,3,4,5,6,7,8,10,12,15,24,36,48,60,72h post-dose
measure: Maximum of concentration (Cmax) of Evogliptin and Metformin
timeFrame: 1d(15d) pre-dose, 1,2,3,4,5,6,7,8,10,12,15,24,36,48,60,72h post-dose
Secondary outcomes:
measure: Time of maximum concentration(Tmax) of Evogliptin and Metformin
timeFrame: 1d(15d) pre-dose, 1,2,3,4,5,6,7,8,10,12,15,24,36,48,60,72h post-dose
measure: Terminal half-life(t1/2) of Evogliptin and Metformin
timeFrame: 1d(15d) pre-dose, 1,2,3,4,5,6,7,8,10,12,15,24,36,48,60,72h post-dose
measure: Apparent Clearance(CL/F) of Evogliptin and Metformin
timeFrame: 1d(15d) pre-dose, 1,2,3,4,5,6,7,8,10,12,15,24,36,48,60,72h post-dose
measure: Area Under Curve(AUC)inf of Evogliptin and Metformin
timeFrame: 1d(15d) pre-dose, 1,2,3,4,5,6,7,8,10,12,15,24,36,48,60,72h post-dose
measure: Time prior to the first measurable concentration (tlag) of Metformin (only in Part 2 trial)
timeFrame: 1d(15d) pre-dose, 1,2,3,4,5,6,7,8,10,12,15,24,36,48,60,72h post-dose
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Clinical Trial Center, Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Kyung-sang Yu, Ph.d., M.B.A
role: PRINCIPAL_INVESTIGATOR
References: