Clinical trial NCT02670018: BE Study of the Combinations of Gemigliptin 50mg and Metformin HCl Extended Release 2000mg in Comparison to Each Component Administered Alone
Official title: A Randomized, Open-label, Single-dose, Two-way Crossover Clinical Trial to Investigate the Pharmacokinetics and Safety/Tolerability of the Combination of Gemigliptin/Metformin HCl Sustained Release 50/2000 mg(25/1000 mg x 2 Tablets) in Comparison to Each Component Gemigliptin 50 mg and Metformin HCl Extended Release 2000 mg(1000 mg x 2 Tablets) Administered in Healthy Male Volunteers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Healthy
Lead sponsor: LG Life Sciences
Sponsor class: INDUSTRY
First posted: 2016-02-01
Enrollment: 25
Sex: MALE
Minimum age (years): 19
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: A Randomized, Open-label, Single-dose, Two-way Crossover Clinical Trial to Investigate the Pharmacokinetics and Safety/Tolerability of the Combination of Gemigliptin/Metformin HCl Sustained Release 50/2000 mg(25/1000 mg x 2 tablets) in Comparison to Each Component Gemigliptin 50 mg and Metformin HCl Extended Release 2000 mg (1000 mg x 2 tablets) Administered in Healthy Male Volunteers.


Eligibility criteria: Inclusion Criteria:

* Age between 19 to 45, healthy male subjects(at screening)
* Body weight between 55kg - 90kg, BMI between 18.0 - 27.0
* FPG 70-125mg/dL glucose level(at screening)
* Subject who totally understand the progress of this clinical trials, make decision by his free will, and signed a consent form to follow the progress.

Exclusion Criteria:

* Subject who has past or present history of any diseases following below.(liver including hepatitis virus carrier, kidney, Neurology,immunology,pulmonary,endocrine,hematooncology,cardiology,mental disorder.)
* Subject who had GI tract disease or(ulcer, acute or chronic pancreatitis) surgery.(appendectomy, hernioplasty are not included)
* Subject who had drug hypersensitivity reaction.(Aspirin, antibiotics)
* Subject who already participated in other trials in 3months
* Subject who had whole blood donation in 2months, or component blood donation in 1months or transfusion in 1months currently.
* Smokers.(but, if the subject did'nt smoke in 3months, can participate the trial)

Primary outcomes:
measure: AUClast
timeFrame: up to 48h post-dose
measure: Cmax
timeFrame: up to 48h post-dose
Secondary outcomes:
measure: Tmax of Gemigliptin, Metformin
timeFrame: up to 48h post-dose
measure: AUCinf of Gemigliptin, Metformin
timeFrame: up to 48h post-dose
measure: t1/2 of Gemigliptin, Metformin
timeFrame: up to 48h post-dose
measure: CL/F of Gemigliptin, Metformin
timeFrame: up to 48h post-dose
measure: Vd/F of Gemigliptin, Metformin
timeFrame: up to 48h post-dose
measure: AUC0-48h of Gemigliptin metabolite(LC15-0636)
timeFrame: up to 48h post-dose
measure: Cmax of Gemigliptin metabolite(LC15-0636)
timeFrame: up to 48h post-dose
measure: Tmax of Gemigliptin metabolite(LC15-0636)
timeFrame: up to 48h post-dose
measure: AUCinf of Gemigliptin metabolite(LC15-0636)
timeFrame: up to 48h post-dose
measure: t1/2 of Gemigliptin metabolite(LC15-0636)
timeFrame: up to 48h post-dose
measure: CL/F of Gemigliptin metabolite(LC15-0636)
timeFrame: up to 48h post-dose
measure: Vd/F of Gemigliptin metabolite(LC15-0636)
timeFrame: up to 48h post-dose
measure: metabolic ratio(MR) of Gemigliptin metabolite(LC15-0636)
timeFrame: up to 48h post-dose
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Yonsei University College of Medicine
Study officials:
References: