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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Gemigliptin and Glimepiride

Multiple administrations of gemigliptin and single concomitant administration of gemigliptin and glimepiride

Group Type EXPERIMENTAL

Gemigliptin and Glimepiride

Intervention Type DRUG

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

Glimepiride

Single administration of glimepiride

Group Type EXPERIMENTAL

Glimepiride

Intervention Type DRUG

Glimepiride 4mg (qd) on Day1

Interventions

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Gemigliptin and Glimepiride

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

Intervention Type DRUG

Glimepiride

Glimepiride 4mg (qd) on Day1

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes