Pharmacokinetic Drug Interaction Study Between Gemigliptin and Glimepiride in Healthy Male Subjects

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LG Life Sciences

Status and phase

Completed
Phase 1

Conditions

Healthy

Treatments

Drug: Gemigliptin and Glimepiride
Drug: Glimepiride

Study type

Interventional

Funder types

Industry

Identifiers

NCT01768455
LG-DPCL013

Details and patient eligibility

About

The objective of the study was to investigate the pharmacokinetic drug interaction between gemigliptin and glimepiride in healthy male subjects after oral administration concomitantly and each alone.

Enrollment

27 patients

Sex

Male

Ages

20 to 45 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Age between 20 to 45, healthy male subjects (at screening)
  • BMI between 18 - 27 (at screening)
  • 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

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.(gemigliptin, glimepiride, aspirin, antibiotics)
  • Subject who already participated in other trials in 90 days
  • Subject who had whole blood donation in 60 days, or component blood donation in 30 days or transfusion in 30 days currently

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

27 participants in 2 patient groups

Gemigliptin and Glimepiride
Experimental group
Description:
Multiple administrations of gemigliptin and single concomitant administration of gemigliptin and glimepiride
Treatment:
Drug: Gemigliptin and Glimepiride
Glimepiride
Experimental group
Description:
Single administration of glimepiride
Treatment:
Drug: Glimepiride

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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