Back to resultsA Clinical Trial to Investigate Safety/Tolerability and Pharmacokinetics of DA-1229_01(Evogliptin/Metformin XR 2.5/500 mg x 2 Tablets) Compared to Co-administration of Evogliptin 5 mg and Metformin XR 1000 mg in Healthy Male Volunteers
Primary Purpose
Type 2 Diabetes Mellitus
Status
Completed
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
DA-1229_01
E+M
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes Mellitus
Eligibility Criteria
Inclusion Criteria:
- Age between 19 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
Sites / Locations
- Clinical Trial Center, Seoul National University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
DA-1229_01 → E+M
E+M → DA-1229_01
Arm Description
DA-1229_01 : Evogliptin/Metformin XR 2.5/500mg x 2 Tablets E : Evogliptin 5 mg M : Metformin XR 1000 mg
DA-1229_01 : Evogliptin/Metformin XR 2.5/500mg x 2 Tablets E : Evogliptin 5 mg M : Metformin XR 1000 mg
Outcomes
Primary Outcome Measures
Area Under Curve(AUC)last of Evogliptin and Metformin
Maximum of concentration (Cmax) of Evogliptin and Metformin
Secondary Outcome Measures
Time of maximum concentration(Tmax) of Evogliptin and Metformin
Terminal half-life(t1/2) of Evogliptin and Metformin
Apparent Clearance(CL/F) of Evogliptin and Metformin
Area Under Curve(AUC)inf of Evogliptin and Metformin
AUCinf = AUC last + Clast/λz
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02375139
Brief Title
A Clinical Trial to Investigate Safety/Tolerability and Pharmacokinetics of DA-1229_01(Evogliptin/Metformin XR 2.5/500 mg x 2 Tablets) Compared to Co-administration of Evogliptin 5 mg and Metformin XR 1000 mg 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 2.5/500 mg x 2 Tablets) Compared to Co-administration of Evogliptin 5 mg and Metformin XR 1000 mg After Single Oral Administration in Healthy Male Volunteers
Study Type
Interventional
2. Study Status
Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
April 2015 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dong-A ST Co., Ltd.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This Phase I clinical study is to evaluate the safety/tolerability and pharmacokinetics of DA-1229_01(Evogliptin/Metformin XR 2.5/500 mg x 2 tablets).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
DA-1229_01 → E+M
Arm Type
Experimental
Arm Description
DA-1229_01 : Evogliptin/Metformin XR 2.5/500mg x 2 Tablets E : Evogliptin 5 mg M : Metformin XR 1000 mg
Arm Title
E+M → DA-1229_01
Arm Type
Experimental
Arm Description
DA-1229_01 : Evogliptin/Metformin XR 2.5/500mg x 2 Tablets E : Evogliptin 5 mg M : Metformin XR 1000 mg
Intervention Type
Drug
Intervention Name(s)
DA-1229_01
Other Intervention Name(s)
Evogliptin/Metformin XR 2.5/500 mg x 2 Tablets
Intervention Description
complex single administration
Intervention Type
Drug
Intervention Name(s)
E+M
Other Intervention Name(s)
Evogliptin 5 mg + Metformin XR 1000 mg
Intervention Description
co-administration of 2 drugs
Primary Outcome Measure Information:
Title
Area Under Curve(AUC)last of Evogliptin and Metformin
Time Frame
1d(15d) pre-dose, 1,2,3,4,5,6,7,8,10,12,15,24,36,48,60,72h post-dose
Title
Maximum of concentration (Cmax) of Evogliptin and Metformin
Time Frame
1d(15d) pre-dose, 1,2,3,4,5,6,7,8,10,12,15,24,36,48,60,72h post-dose
Secondary Outcome Measure Information:
Title
Time of maximum concentration(Tmax) of Evogliptin and Metformin
Time Frame
1d(15d) pre-dose, 1,2,3,4,5,6,7,8,10,12,15,24,36,48,60,72h post-dose
Title
Terminal half-life(t1/2) of Evogliptin and Metformin
Time Frame
1d(15d) pre-dose, 1,2,3,4,5,6,7,8,10,12,15,24,36,48,60,72h post-dose
Title
Apparent Clearance(CL/F) of Evogliptin and Metformin
Time Frame
1d(15d) pre-dose, 1,2,3,4,5,6,7,8,10,12,15,24,36,48,60,72h post-dose
Title
Area Under Curve(AUC)inf of Evogliptin and Metformin
Description
AUCinf = AUC last + Clast/λz
Time Frame
1d(15d) pre-dose, 1,2,3,4,5,6,7,8,10,12,15,24,36,48,60,72h post-dose
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age between 19 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kyung-sang Yu, Ph.D, M.B.A
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinical Trial Center, Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
A Clinical Trial to Investigate Safety/Tolerability and Pharmacokinetics of DA-1229_01(Evogliptin/Metformin XR 2.5/500 mg x 2 Tablets) Compared to Co-administration of Evogliptin 5 mg and Metformin XR 1000 mg in Healthy Male Volunteers
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