Gemigliptin, Dapagliflozin, Empagliflozin DDI Study

NCT03565458 | Unknown Phase 1

• 1 other identifier: LG-DPCL018
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

gemigliptin,SGLT-2i DDI study

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (2)

• Area under the plasma concentration versus time curve (AUC) of gemigliptin, dapagliflozin, empagliflozin

  AUCτ

  day1, day6, day7 0, 0.5, 1,1.5,2,2.5,3,4,5,6,8,12,16,24 hours

• 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 Outcomes (6)

• 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

• 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

• 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

• 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

• 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

Study Arms (5)

gemigliptin

EXPERIMENTAL

gemigliptin single dose

Drug: Gemigliptin

dapagliflozin

EXPERIMENTAL

dapagliflozin single dose

Drug: Dapagliflozin

gemigliptin and dapagliflozin

EXPERIMENTAL

co-administration of gemigliptin and dapagliflozin

Drug: Gemigliptin; Drug: Dapagliflozin

empagliflozin

EXPERIMENTAL

empagliflozin single dose

Drug: Empagliflozin

gemigliptin and empagliflozin

EXPERIMENTAL

co-administration of gemigliptin and empagliflozin

Drug: Gemigliptin; Drug: Empagliflozin

Interventions

Gemigliptin DRUG

zemiglo 50mg,LG Chem

Also known as: zemiglo

gemigliptin; gemigliptin and dapagliflozin; gemigliptin and empagliflozin

Dapagliflozin DRUG

forxiga, dapagliflozin 10mg

Also known as: forxiga

dapagliflozin; gemigliptin and dapagliflozin

Empagliflozin DRUG

jardiance 25mg, empagliflozin

Also known as: jardiance

empagliflozin; gemigliptin and empagliflozin

Eligibility Criteria

• Age: 19 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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
• 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).
• Subject who had infection disease or serious injury within 21 days before the randomization
• Subject with genetic problems such as galactose intolerance, Lapp lactose dehydrogenase deficiency or glucose-galactose uptake disorder
• Subject who do not have a medically approved contraceptive during the period of the clinical trial, or who plan to provide sperm
• Subject who have received a clinical trial drug or a bioequivalence study drug within 90 days of the random allocation
• 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
• Subject who had whole blood donation within 60 days or component blood donation within 30 days before the randomization
• subject who drinks the average amount per week exceeding 140 g of alcohol
• Subject whose daily average smoking amount exceeds 20 pieces per day
• Average daily grapefruit juice intake exceeding 2 cups
• 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
• 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
• 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
• Subject who do not show a negative response in the hepatitis B test, hepatitis C test, HIV test and syphilis test

Sponsors & Collaborators

• LG Chem: lead

Study Sites (1)

LG chem

Seoul, Gangseo-Gu, 07795, South Korea

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

LC15-0444; dapagliflozin; empagliflozin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• jungryul kim, doctor

  samsung seoul medical center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2018
• First Posted: June 21, 2018
• Study Start: April 5, 2018
• Primary Completion: August 20, 2018
• Study Completion: December 22, 2018
• Last Updated: June 21, 2018

Record last verified: 2018-05

Locations

KR (1)