NCT01768455

Brief Summary

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at P25-P50 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 13, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 15, 2013

Completed
17 days until next milestone

Study Start

First participant enrolled

February 1, 2013

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
Last Updated

April 23, 2013

Status Verified

April 1, 2013

Enrollment Period

2 months

First QC Date

January 13, 2013

Last Update Submit

April 22, 2013

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

  • AUC

    To evaluate AUCτ,ss of gemigliptin and AUClast of glimepiride

    up to 24h post-dose

  • Cmax

    To evaluate Cmax,ss of gemigliptin and Cmax of glimepiride

    up to 24h post-dose

Secondary Outcomes (4)

  • Tmax

    up to 24h post-dose

  • t1/2β

    up to 24h post-dose

  • AUC

    up to 24h post-dose

  • Cmax

    up to 24h post-dose

Study Arms (2)

Gemigliptin and Glimepiride

EXPERIMENTAL

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

Drug: Gemigliptin and Glimepiride

Glimepiride

EXPERIMENTAL

Single administration of glimepiride

Drug: Glimepiride

Interventions

Gemigliptin and GlimepirideDRUG

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

Gemigliptin and Glimepiride
GlimepirideDRUG

Glimepiride 4mg (qd) on Day1

Glimepiride

Eligibility Criteria

Age20 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asan Medical Center

Seoul, South Korea

Location

MeSH Terms

Interventions

LC15-0444glimepiride

Study Officials

  • Kyun-Seop Bae, M.D., Ph.D.

    Asan Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 13, 2013

First Posted

January 15, 2013

Study Start

February 1, 2013

Primary Completion

April 1, 2013

Last Updated

April 23, 2013

Record last verified: 2013-04

Locations

KR(1)