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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.

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).

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: DA-1229_01 Drug: E+M Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : April 2015
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
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

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
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




Primary Outcome Measures :
  1. 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 ]
  2. 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 Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. 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



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Ages Eligible for Study:   19 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02375139


Locations
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Korea, Republic of
Clinical Trial Center, Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
Sponsors and Collaborators
Dong-A ST Co., Ltd.
Investigators
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Principal Investigator: Kyung-sang Yu, Ph.D, M.B.A Seoul National University Hospital

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Responsible Party: Dong-A ST Co., Ltd.
ClinicalTrials.gov Identifier: NCT02375139     History of Changes
Other Study ID Numbers: DA-1229_01
First Posted: March 2, 2015    Key Record Dates
Last Update Posted: July 22, 2015
Last Verified: July 2015
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs