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Pharmacokinetic and Pharmacodynamic Drug-Drug Interaction of Evogliptin and Empagliflozin or Dapagliflozin in Healthy Male Adults

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03766724
Recruitment Status : Active, not recruiting
First Posted : December 6, 2018
Last Update Posted : December 6, 2018
Sponsor:
Information provided by (Responsible Party):
Dong-A ST Co., Ltd.

Brief Summary:
A Randomized, Open-label, Multiple-dose, Crossover Study to Investigate the Pharmacokinetic and Pharmacodynamic Drug-Drug Interaction of Evogliptin 5 mg and Empagliflozin 25 mg or Dapagliflozin 10 mg after Oral Administration in Healthy Male Adults

Condition or disease Intervention/treatment Phase
Type2 Diabetes Drug: Evogliptin, Evogliptin+Empagliflozin, Empagliflozin Drug: Empagliflozin, Evogliptin, Evogliptin+Empagliflozin Drug: Evogliptin, Evogliptin+Dapagliflozin, Dapagliflozin Drug: Dapagliflozin, Evogliptin, Evogliptin+Dapagliflozin Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: A Randomized, Open-label, Multiple-dose, Crossover Study to Investigate the Pharmacokinetic and Pharmacodynamic Drug-Drug Interaction of Evogliptin 5 mg and Empagliflozin 25 mg or Dapagliflozin 10 mg After Oral Administration in Healthy Male Adults
Actual Study Start Date : November 22, 2018
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : January 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drug Reactions

Arm Intervention/treatment
Experimental: Group A
Evogliptin Evogliptin+Empagliflozin Empagliflozin
Drug: Evogliptin, Evogliptin+Empagliflozin, Empagliflozin
Evogliptin : Evogliptin 5mg QD, Evogliptin+Empagliflozin : Evogliptin 5mg QD + Empagliflozin 25mg QD, Empagliflozin : Empagliflozin 25mg QD
Other Names:
  • Suganon
  • Jardiance

Experimental: Group B
Empagliflozin Evogliptin Evogliptin+Empagliflozin
Drug: Empagliflozin, Evogliptin, Evogliptin+Empagliflozin
Empagliflozin : Empagliflozin 25mg QD, Evogliptin : Evogliptin 5mg QD, Evogliptin+Empagliflozin : Evogliptin 5mg QD + Empagliflozin 25mg QD
Other Names:
  • Suganon
  • Jardiance

Experimental: Group C
Evogliptin Evogliptin+Dapagliflozin Dapagliflozin
Drug: Evogliptin, Evogliptin+Dapagliflozin, Dapagliflozin
Evogliptin : Evogliptin 5mg QD, Evogliptin+Dapagliflozin : Evogliptin 5mg QD + Dapagliflozin 10mg QD, Dapagliflozin : Dapagliflozin 10mg QD
Other Names:
  • Suganon
  • Forxiga

Experimental: Group D
Dapagliflozin Evogliptin Evogliptin+Dapagliflozin
Drug: Dapagliflozin, Evogliptin, Evogliptin+Dapagliflozin
Dapagliflozin : Dapagliflozin 10mg QD, Evogliptin : Evogliptin 5mg QD, Evogliptin+Dapagliflozin : Evogliptin 5mg QD + Dapagliflozin 10mg QD
Other Names:
  • Suganon
  • Forxiga




Primary Outcome Measures :
  1. AUCτ,ss [ Time Frame: 4 weeks ]
    area under the concentration-time curve

  2. Cmax,ss [ Time Frame: 4 weeks ]
    maximum serum concentration



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Health Male Volunteers (Age : 19~55 years)
  • Body Weight≥55kg, 18.5≤BMI<25.0

Exclusion Criteria:

  • galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption
  • Allergy or Drug hypersensitivity
  • Clinically significant Medical History
  • AST, ALT > Upper Normal Range*1.25, eGFR<60mL/min/1.73㎡
  • 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): NCT03766724


Locations
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Korea, Republic of
Clinical Trials Center, Severance Hospital
Seoul, Korea, Republic of, 03722
Sponsors and Collaborators
Dong-A ST Co., Ltd.
Investigators
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Principal Investigator: Min soo Park, M.D., Ph.D. Clinical Trial Center, Severance Hospital

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Responsible Party: Dong-A ST Co., Ltd.
ClinicalTrials.gov Identifier: NCT03766724     History of Changes
Other Study ID Numbers: DA1229_DIS_I
First Posted: December 6, 2018    Key Record Dates
Last Update Posted: December 6, 2018
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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2-(3-(4-ethoxybenzyl)-4-chlorophenyl)-6-hydroxymethyltetrahydro-2H-pyran-3,4,5-triol
Empagliflozin
Sodium-Glucose Transporter 2 Inhibitors
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents
Physiological Effects of Drugs