Skip to main content
OpenTrials
Completed

NCT Number: NCT01768455

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy

Age range

20 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Asan Medical Center

Seoul, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Gemigliptin and Glimepiride

Drug

Gemigliptin 50mg (qd) on Day1~Day6 and Gemigliptin 50mg (qd) and Glimepiride 4mg (qd) on Day7

Glimepiride

Drug

Glimepiride 4mg (qd) on Day1

Primary outcomes

  1. AUC

    Time frame: up to 24h post-dose

    To evaluate AUCτ,ss of gemigliptin and AUClast of glimepiride

  2. Cmax

    Time frame: up to 24h post-dose

    To evaluate Cmax,ss of gemigliptin and Cmax of glimepiride

Secondary outcomes

  1. Tmax

    Time frame: up to 24h post-dose

    To evaluate Tmax,ss of gemigliptin/LC15-0636 and Tmax of glimepiride/M1

  2. t1/2β

    Time frame: up to 24h post-dose

    To evaluate t1/2β of gemigliptin/LC15-0636/glimepiride/M1

  3. AUC

    Time frame: up to 24h post-dose

    To evaluate AUCτ,ss of LC15-0636 and AUClast of M1

  4. Cmax

    Time frame: up to 24h post-dose

    To evaluate Cmax,ss of LC15-0636 and Cmax of M1

Sponsors and collaborators

Lead sponsor

LG Life Sciences

Industry

Registry information

Official study title

A Randomized, Open Label Crossover Study to Investigate the Pharmacokinetic Drug Interaction Between Gemigliptin and Glimepiride in Healthy Male Subjects

Important dates

Study start
2013
Primary completion
2013
First posted
Jan 15, 2013
Registry last updated
Apr 23, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.