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

December 29, 2014 updated by: LG Life Sciences

A Randomized, Open Label Crossover Study to Investigate the Pharmacokinetic Drug Interactions Between Gemigliptin and Irbesartan 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Gemigliptin
Gemigliptin 50mg q.d. during 7 days
Drug: Gemigliptin
Experimental: Irbesartan
Irbesartan 300mg q.d. during 7 days
Drug: Irbesartan
Experimental: Gemiglitin + Irbesartan
Gemigliptin 50mg + Irbesartan 300mg q.d. during 7 days
Drug: Irbesartan
Drug: Gemigliptin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cmax,ss
Time Frame: up to 72h post-dose
To evaluate Cmax,ss of Gemigliptin and Irbesartan
up to 72h post-dose
AUCτ,ss
Time Frame: up to 72h post-dose
To evaluate AUCτ,ss of Gemigliptin and Irbesartan
up to 72h post-dose

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cmin,ss
Time Frame: up to 72h post-dose
To evaluate Cmin,ss of Gemigliptin and Irbesartan
up to 72h post-dose
Tmax,ss
Time Frame: up to 72h post-dose
To evaluate Tmax,ss of Gemigliptin, Irbesartan and LC15-0636 (active metaboilite of Gemigliptin)
up to 72h post-dose
Cmax,ss
Time Frame: up to 72h post-dose
To evaluate Cmax,ss of LC15-0636 (active metaboilite of Gemigliptin)
up to 72h post-dose
AUCτ,ss
Time Frame: up to 72h post-dose
To evaluate AUCτ,ss of LC15-0636(active metabolite of Gemigliptin)
up to 72h post-dose
metabolic ratio
Time Frame: up to 72h post-dose
To evaluate metabolic ratio of LC15-0636(active metabolite of Gemigliptin)
up to 72h post-dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

LG Life Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (Actual)

September 1, 2013

Study Completion (Actual)

March 1, 2014

Study Registration Dates

First Submitted

April 3, 2013

First Submitted That Met QC Criteria

April 3, 2013

First Posted (Estimate)

April 8, 2013

Study Record Updates

Last Update Posted (Estimate)

December 30, 2014

Last Update Submitted That Met QC Criteria

December 29, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LG-GBCL001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Locations

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