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Gemigliptin, Dapagliflozin, Empagliflozin DDI Study

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ClinicalTrials.gov Identifier: NCT03565458
Recruitment Status : Active, not recruiting
First Posted : June 21, 2018
Last Update Posted : June 21, 2018
Sponsor:
Information provided by (Responsible Party):
LG Chem

Brief Summary:
gemigliptin,SGLT-2i DDI study

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: Gemigliptin Drug: Dapagliflozin Drug: Empagliflozin Phase 1

Detailed Description:
LG-DPCL018 (gemigliptin,SGLT-2i DDI study) is to evaluate the safety and immunogenicity of gemilgliptin & dapagliflozin and gemigliptin & empagliflozin.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label, Randomized, Multiple-dose, Crossover Study to Evaluate Drug-drug Interaction Following Oral Administration of Gemigliptin and Dapagliflozin or Empagliflozin in Healthy Adult Volunteers
Actual Study Start Date : April 5, 2018
Estimated Primary Completion Date : August 20, 2018
Estimated Study Completion Date : December 22, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: gemigliptin
gemigliptin single dose
Drug: Gemigliptin
zemiglo 50mg,LG Chem
Other Name: zemiglo

Experimental: dapagliflozin
dapagliflozin single dose
Drug: Dapagliflozin
forxiga, dapagliflozin 10mg
Other Name: forxiga

Experimental: gemigliptin and dapagliflozin
co-administration of gemigliptin and dapagliflozin
Drug: Gemigliptin
zemiglo 50mg,LG Chem
Other Name: zemiglo

Drug: Dapagliflozin
forxiga, dapagliflozin 10mg
Other Name: forxiga

Experimental: empagliflozin
empagliflozin single dose
Drug: Empagliflozin
jardiance 25mg, empagliflozin
Other Name: jardiance

Experimental: gemigliptin and empagliflozin
co-administration of gemigliptin and empagliflozin
Drug: Gemigliptin
zemiglo 50mg,LG Chem
Other Name: zemiglo

Drug: Empagliflozin
jardiance 25mg, empagliflozin
Other Name: jardiance




Primary Outcome Measures :
  1. Area under the plasma concentration versus time curve (AUC) of gemigliptin, dapagliflozin, empagliflozin [ Time Frame: day1, day6, day7 0, 0.5, 1,1.5,2,2.5,3,4,5,6,8,12,16,24 hours ]
    AUCτ

  2. Peak Plasma Concentration (Cmax) of gemigliptin, dapagliflozin, empagliflozin [ Time Frame: day1, day6, day7 0, 0.5, 1,1.5,2,2.5,3,4,5,6,8,12,16,24 hours ]
    Css,max


Secondary Outcome Measures :
  1. tss,max of gemigliptin, dapagliflozin, empagliflozin [ Time Frame: day1, day6, day7 0, 0.5, 1,1.5,2,2.5,3,4,5,6,8,12,16,24 hours ]
    tss,max

  2. minimum blood plasma concentration of gemigliptin, dapagliflozin, empagliflozin [ Time Frame: day1, day6, day7 0, 0.5, 1,1.5,2,2.5,3,4,5,6,8,12,16,24 hours ]
    Css,min

  3. Area under the plasma concentration versus time curve (AUC) of gemigliptin metabolite [ Time Frame: day1,day6,day7 0, 0.5, 1,1.5,2,2.5,3,4,5,6,8,12,16,24 hours ]
    AUCτ

  4. Peak Plasma Concentration (Cmax)of gemigliptin metabolite [ Time Frame: day1,day6,day7 0, 0.5, 1,1.5,2,2.5,3,4,5,6,8,12,16,24 hours ]
    Css,max

  5. minimum blood plasma concentration(Css,min) of gemigliptin metabolite [ Time Frame: day1,day6,day7 0, 0.5, 1,1.5,2,2.5,3,4,5,6,8,12,16,24 hours ]
    Css,min

  6. metabolic ratio of gemigliptin [ Time Frame: day1,day6,day7 0, 0.5, 1,1.5,2,2.5,3,4,5,6,8,12,16,24 hours ]
    metabolic ratio



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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:

  1. Healthy male adults at age between 19 to 55 at the time of the screening
  2. Those whose BMI measurement result at screening visit is between 18 and 27 kg/m2
  3. Subject who has voluntarily decided to participate in this clinical trial and consented after listening all procedures and objects of this clinical trial
  4. subjects who is consented in writing to be sure to comply with the requirements of the clinical trial

Exclusion Criteria:

  1. Subject who has past or present history of a clinically significant disease such as hepatic, renal, immunological, respiratory, musculoskeletal, endocrine, neurological, hemato-oncological, or cardiovascular disorder
  2. Subject showing hypersensitivity reaction or having a history of hypersensitivity reaction that is clinically significant to gemigliptin or dapagliflozin or empagliflozin ingredients, drugs that contain same class of ingredients or other drugs(DPP-4i, SGLT-2i).
  3. Subject who had infection disease or serious injury within 21 days before the randomization
  4. Subject with genetic problems such as galactose intolerance, Lapp lactose dehydrogenase deficiency or glucose-galactose uptake disorder
  5. Subject who do not have a medically approved contraceptive during the period of the clinical trial, or who plan to provide sperm
  6. Subject who have received a clinical trial drug or a bioequivalence study drug within 90 days of the random allocation
  7. Those who have received a drug that can significantly affect the absorption, distribution, metabolism or excretion of the clinical trial drug within 30 days of randomization
  8. Subject who had whole blood donation within 60 days or component blood donation within 30 days before the randomization
  9. subject who drinks the average amount per week exceeding 140 g of alcohol
  10. Subject whose daily average smoking amount exceeds 20 pieces per day
  11. Average daily grapefruit juice intake exceeding 2 cups
  12. Subject who had a systolic blood pressure less than 100 mmHg, greater than 150 mmHg, diastolic blood pressure less than 70 mmHg, or greater than 100 mmHg at the time of screening test
  13. Subject with a glomerular filtration rate of less than 60 mL / min / 1.73m^2 calculated from serum creatinine values at the time of screening
  14. Subject whose blood creatinine, AST, ALT or γ-GT levels exceeded the upper limit of the reference range by 1.5 times the screening test
  15. Subject who do not show a negative response in the hepatitis B test, hepatitis C test, HIV test and syphilis test
  16. Subject who are sensitive to the ingredients of Yellow No. 5 or have an allergy history
  17. Subject who have clinically significant abnormalities in other clinical tests
  18. Subject with clinically significant abnormal ECG findings
  19. Subject who is considered to be unsuitable in conducting the clinical trial at the principal investigator's discretionary judgment

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): NCT03565458


Locations
Korea, Republic of
LG chem
Seoul, Gangseo-Gu, Korea, Republic of, 07795
Sponsors and Collaborators
LG Chem
Investigators
Principal Investigator: jungryul kim, doctor samsung seoul medical center

Responsible Party: LG Chem
ClinicalTrials.gov Identifier: NCT03565458     History of Changes
Other Study ID Numbers: LG-DPCL018
First Posted: June 21, 2018    Key Record Dates
Last Update Posted: June 21, 2018
Last Verified: May 2018

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

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Empagliflozin
Hypoglycemic Agents
Physiological Effects of Drugs