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Pharmacokinetic/Pharmacodynamic Drug-drug Interaction of Evogliptin 5mg and Glimepiride 4mg

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ClinicalTrials.gov Identifier: NCT02954822
Recruitment Status : Completed
First Posted : November 3, 2016
Last Update Posted : September 18, 2017
Sponsor:
Information provided by (Responsible Party):
Dong-A ST Co., Ltd.

Brief Summary:
A randomized, open-label, multiple dosing, three treatment, three period, two sequence clinical trial to investigate the pharmacokinetic/pharmacodynamic drug-drug interaction of evogliptin 5 mg and glimepiride 4 mg after oral administration in healthy male subjects

Condition or disease Intervention/treatment Phase
Type2 Diabetes Drug: Evogliptin→Evogliptin+Glimepiride→Glimepiride Drug: Glimepiride→Evogliptin→Evogliptin+Glimepiride Phase 1

Detailed Description:
A randomized, open-label, multiple-dose, three-treatment, three-period, two-sequence, crossover study

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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: Health Services Research
Official Title: A Randomized, Open-label, Multiple Dosing, Cross-over Clinical Trial to Investigate the Pharmacokinetic/Pharmacodynamic Drug-drug Interaction of Evogliptin 5mg and Glimepiride 4mg After Oral Administration in Healthy Male Subjects
Actual Study Start Date : November 14, 2016
Actual Primary Completion Date : January 25, 2017
Actual Study Completion Date : August 9, 2017


Arm Intervention/treatment
Experimental: (Group A)
Evogliptin→Evogliptin+Glimepiride→Glimepiride
Drug: Evogliptin→Evogliptin+Glimepiride→Glimepiride

Evogliptin 5mg will be administered for 7days and then glimepiride 4mg will be added on and administered with Evogliptin 5mg for 2 days. After the washout period for 10 days, Glimepiride 4mg will be administered for 2 days.

Glimepiride : Glimepiride 4mg QD

Evogliptin + Glimepiride : Evogliptin 5mg QD + Glimepiride 4mg QD

Other Name: Suganon, Amaryl

Experimental: (Group B)
Glimepiride→Evogliptin→Evogliptin+Glimepiride
Drug: Glimepiride→Evogliptin→Evogliptin+Glimepiride
After 2 days of administration of Glimepiride 4mg follows the 10-day washout period. Afterwards Evogliptin 5mg will be administered for 7days and then glimepiride 4mg will be added on and administered with Evogliptin 5mg for 2 days.
Other Name: Suganon, Amaryl




Primary Outcome Measures :
  1. AUCτ,ss for Evogliptin and Glimepiride [ Time Frame: 3 weeks ]
    area under the concentration-time curve



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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:

  • Healthy Male Volunteers (Age: 19~45years)
  • 55<Body Weight<90, 18<BMI<27
  • FPG: 70-125 mg/dL

Exclusion Criteria:

  • galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption
  • Clinically significant Medical History
  • Allergy or Drug Hypersensitivity
  • AST(SGOT), ALT(SGPT) > Upper Normal Range*1.5, eGFR<80 mL/min
  • Drink during clinical trial period
  • Smoking during clinical trial period
  • Grapefruit/Caffeine intake during clinical trial period
  • No Contraception

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): NCT02954822


Locations
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Korea, Republic of
Clinical Trials Center, Seoul National University Hospital
Seoul, Korea, Republic of, 03080
Sponsors and Collaborators
Dong-A ST Co., Ltd.
Investigators
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Principal Investigator: Kyung-Sang Yu, M.D., Ph.D. Clinical Trial Center, Seoul National University Hospital
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Responsible Party: Dong-A ST Co., Ltd.
ClinicalTrials.gov Identifier: NCT02954822    
Other Study ID Numbers: DA1229_DIG_I
First Posted: November 3, 2016    Key Record Dates
Last Update Posted: September 18, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Glimepiride
Anti-Arrhythmia Agents
Hypoglycemic Agents
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors