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Completed

NCT Number: NCT01825850

Pharmacokinetic Drug Interaction Study Between Gemigliptin and Irbesartan After Oral Administration in Healthy Male Subjects

The objective of the study is to investigate the drug interaction between Gemigliptin and Irbesartan by comparing pharmacokinetics of Gemigliptin and Irbesartan administered concomitantly and each alone in healthy male subjects.

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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 kg/m2 (at screening)
  • Blood pressure SBP 90-140 mmHg, DBP 60-95 mmHg
  • 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 that influencable to drug absorption or(ulcer, acute or chronic pancreatitis) surgery.(appendectomy, hernioplasty are not included)
  • Subject who had drug hypersensitivity reaction.(gemigliptin, irbesartan, aspirin, antibiotics)
  • Subject who already admitted in other investigator product in 80 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

Drug

Irbesartan

Drug

Primary outcomes

  1. Cmax,ss

    Time frame: up to 72h post-dose

    To evaluate Cmax,ss of Gemigliptin and Irbesartan

  2. AUCτ,ss

    Time frame: up to 72h post-dose

    To evaluate AUCτ,ss of Gemigliptin and Irbesartan

Secondary outcomes

  1. Cmin,ss

    Time frame: up to 72h post-dose

    To evaluate Cmin,ss of Gemigliptin and Irbesartan

  2. Tmax,ss

    Time frame: up to 72h post-dose

    To evaluate Tmax,ss of Gemigliptin, Irbesartan and LC15-0636 (active metaboilite of Gemigliptin)

  3. Cmax,ss

    Time frame: up to 72h post-dose

    To evaluate Cmax,ss of LC15-0636 (active metaboilite of Gemigliptin)

  4. AUCτ,ss

    Time frame: up to 72h post-dose

    To evaluate AUCτ,ss of LC15-0636(active metabolite of Gemigliptin)

  5. metabolic ratio

    Time frame: up to 72h post-dose

    To evaluate metabolic ratio of LC15-0636(active metabolite of Gemigliptin)

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 Interactions Between Gemigliptin and Irbesartan in Healthy Male Subjects

Important dates

Study start
2013
Primary completion
2013
Study completion
2014
First posted
Apr 8, 2013
Registry last updated
Dec 30, 2014

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.

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