Gemigliptin, Dapagliflozin, Empagliflozin DDI Study

Type 2 Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03565458
• Other study ID #: LG-DPCL018
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: April 5, 2018
• Est. completion date: December 22, 2018

Study information

• Verified date: May 2018
• Source: LG Chem
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

gemigliptin,SGLT-2i DDI study

Description:

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 48
• Est. completion date: December 22, 2018
• Est. primary completion date: August 20, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 19 Years to 55 Years

Eligibility

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 ?-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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• Gemigliptin
zemiglo 50mg,LG Chem
• Dapagliflozin
forxiga, dapagliflozin 10mg
• Empagliflozin
jardiance 25mg, empagliflozin

Locations

Country	Name	City	State
Korea, Republic of	LG chem	Seoul	Gangseo-Gu

Sponsors (1)

Lead Sponsor	Collaborator
LG Chem

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the plasma concentration versus time curve (AUC) of gemigliptin, dapagliflozin, empagliflozin	AUCt	day1, day6, day7 0, 0.5, 1,1.5,2,2.5,3,4,5,6,8,12,16,24 hours
Primary	Peak Plasma Concentration (Cmax) of gemigliptin, dapagliflozin, empagliflozin	Css,max	day1, day6, day7 0, 0.5, 1,1.5,2,2.5,3,4,5,6,8,12,16,24 hours
Secondary	tss,max of gemigliptin, dapagliflozin, empagliflozin	tss,max	day1, day6, day7 0, 0.5, 1,1.5,2,2.5,3,4,5,6,8,12,16,24 hours
Secondary	minimum blood plasma concentration of gemigliptin, dapagliflozin, empagliflozin	Css,min	day1, day6, day7 0, 0.5, 1,1.5,2,2.5,3,4,5,6,8,12,16,24 hours
Secondary	Area under the plasma concentration versus time curve (AUC) of gemigliptin metabolite	AUCt	day1,day6,day7 0, 0.5, 1,1.5,2,2.5,3,4,5,6,8,12,16,24 hours
Secondary	Peak Plasma Concentration (Cmax)of gemigliptin metabolite	Css,max	day1,day6,day7 0, 0.5, 1,1.5,2,2.5,3,4,5,6,8,12,16,24 hours
Secondary	minimum blood plasma concentration(Css,min) of gemigliptin metabolite	Css,min	day1,day6,day7 0, 0.5, 1,1.5,2,2.5,3,4,5,6,8,12,16,24 hours
Secondary	metabolic ratio of gemigliptin	metabolic ratio	day1,day6,day7 0, 0.5, 1,1.5,2,2.5,3,4,5,6,8,12,16,24 hours