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BE Study of the Combinations of Gemigliptin 50mg and Metformin HCl Extended Release 2000mg in Comparison to Each Component Administered Alone

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LG Life Sciences

Status and phase

Unknown
Phase 1

Conditions

Healthy

Treatments

Drug: gemigliptin and metformin HCl extended release
Drug: gemigliptin/metformin HCl extended release

Study type

Interventional

Funder types

Industry

Identifiers

NCT02670018
LG-DMCL005

Details and patient eligibility

About

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.

Enrollment

25 patients

Sex

Male

Ages

19 to 45 years old

Volunteers

Accepts Healthy Volunteers

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)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

25 participants in 2 patient groups

G+M
Active Comparator group
Description:
Coadministration of gemigliptin 50mg and metformin HCl extended release 1000mg * 2 tablets
Treatment:
Drug: gemigliptin and metformin HCl extended release
C
Experimental group
Description:
Combination of gemigliptin 25mg/metformin HCl extended release 1000mg * 2 tablets
Treatment:
Drug: gemigliptin/metformin HCl extended release

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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