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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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ClinicalTrials.gov Identifier: NCT02375139
Recruitment Status : Completed
First Posted : March 2, 2015
Last Update Posted : July 22, 2015
Sponsor:
Information provided by (Responsible Party):
Dong-A ST Co., Ltd.

Tracking Information
First Submitted Date  ICMJE February 24, 2015
First Posted Date  ICMJE March 2, 2015
Last Update Posted Date July 22, 2015
Study Start Date  ICMJE April 2015
Actual Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 27, 2015)
  • 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 ]
  • 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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02375139 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 27, 2015)
  • 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 ]
  • 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 ]
  • 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 ]
  • Area Under Curve(AUC)inf 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 ]
    AUCinf = AUC last + Clast/λz
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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  ICMJE 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
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Type 2 Diabetes Mellitus
Intervention  ICMJE
  • Drug: DA-1229_01
    complex single administration
    Other Name: Evogliptin/Metformin XR 2.5/500 mg x 2 Tablets
  • Drug: E+M
    co-administration of 2 drugs
    Other Name: Evogliptin 5 mg + Metformin XR 1000 mg
Study Arms  ICMJE
  • Experimental: DA-1229_01 → E+M
    DA-1229_01 : Evogliptin/Metformin XR 2.5/500mg x 2 Tablets E : Evogliptin 5 mg M : Metformin XR 1000 mg
    Interventions:
    • Drug: DA-1229_01
    • Drug: E+M
  • Experimental: E+M → DA-1229_01
    DA-1229_01 : Evogliptin/Metformin XR 2.5/500mg x 2 Tablets E : Evogliptin 5 mg M : Metformin XR 1000 mg
    Interventions:
    • Drug: DA-1229_01
    • Drug: E+M
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 27, 2015)
36
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2015
Actual Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 19 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02375139
Other Study ID Numbers  ICMJE DA-1229_01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dong-A ST Co., Ltd.
Study Sponsor  ICMJE Dong-A ST Co., Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Kyung-sang Yu, Ph.D, M.B.A Seoul National University Hospital
PRS Account Dong-A ST Co., Ltd.
Verification Date July 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP