Gemigliptin, Dapagliflozin, Empagliflozin DDI Study

Phase 1

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: Gemigliptin; Drug: Dapagliflozin; Drug: Empagliflozin

• Registration Number: NCT03565458
• Lead Sponsor: LG Chem

Brief Summary

gemigliptin,SGLT-2i DDI study

Detailed Description

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

Study Timeline

• Study Start: 2018-04-05
• Status Verified: 2018-05
• Study First Submitted: 2018-05-24
• Study First Submitted QC: 2018-06-11
• Last Update Submitted: 2018-06-11
• Study First Posted: 2018-06-21
• Last Update Posted: 2018-06-21
• Primary Completion: 2018-08-20
• Study Completion: 2018-12-22

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 48

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
gemigliptin	Gemigliptin	gemigliptin single dose
dapagliflozin	Dapagliflozin	dapagliflozin single dose
gemigliptin and dapagliflozin	Gemigliptin	co-administration of gemigliptin and dapagliflozin
gemigliptin and empagliflozin	Empagliflozin	co-administration of gemigliptin and empagliflozin
gemigliptin and dapagliflozin	Dapagliflozin	co-administration of gemigliptin and dapagliflozin
empagliflozin	Empagliflozin	empagliflozin single dose
gemigliptin and empagliflozin	Gemigliptin	co-administration of gemigliptin and empagliflozin

Primary Outcome Measures

Name	Time	Method
Area under the plasma concentration versus time curve (AUC) of gemigliptin, dapagliflozin, empagliflozin	day1, day6, day7 0, 0.5, 1,1.5,2,2.5,3,4,5,6,8,12,16,24 hours	AUCτ
Peak Plasma Concentration (Cmax) of gemigliptin, dapagliflozin, empagliflozin	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

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

Trial Locations

Locations (1)

LG chem; 🇰🇷 Seoul, Gangseo-Gu, Korea, Republic of