Study for Investigate the Pharmacokinetic Drug Interactions Between Gemigliptin and Rosuvastatin

August 27, 2013 updated by: LG Life Sciences

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

Investigate the pharmacokinetic drug interactions between gemigliptin and rosuvastatin in healthy subjects

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

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, rosuvastatin, 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

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: gemigliptin only
Multiple administrations of gemigliptin
Drug: gemigliptin only
gemigliptin 50mg qd on day 1~7
EXPERIMENTAL: rosuvastatin only
Multiple administrations of rosuvastatin
Drug: rosuvastatin only
rosuvastatin 20mg qd on day 1~7
EXPERIMENTAL: gemigliptin and rosuvastatin
Multiple administrations of gemigliptin and rosuvastatin
Drug: gemigliptin and rosuvastatin
gemigliptin 50mg, rosuvastatin 20mg qd on day 1~7

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cmax
Time Frame: up to 72 hour post dose
to evaluate Cmax of gemigliptin and rosuvastatin at steady state
up to 72 hour post dose
AUC
Time Frame: up to 72 hour post dose
to evaluate AUCt of gemiglipin, rosuvastatin, and metabolite LC15-0636, N-desmethylrosuvastatin at steady state
up to 72 hour post dose

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tmax
Time Frame: up to 72 hour post dose
to evaluate time of Cmax at steady state, gemiglipin, rosuvastatin, and metabolite LC15-0636, N-desmethylrosuvastatin
up to 72 hour post dose
Cmin
Time Frame: upto 72 hour post dose
to evaluate Cmin of gemigliptin and rosuvastatin at steady state
upto 72 hour post dose
t1/2β
Time Frame: upto 72 hour post dose
to evaluate half-life of gemiglipin, rosuvastatin, and metabolite LC15-0636, N-desmethylrosuvastatin
upto 72 hour post dose
Cmax
Time Frame: upto 72 hour post dose
to evaluate Cmax of metabolite LC15-0636, N-desmethylrosuvastatin at steady state
upto 72 hour post dose
AUC
Time Frame: upto 72 hour post dose
to evaluate AUC of metabolite LC15-0636, N-desmethylrosuvastatin at steady state
upto 72 hour post dose
metabolic ratio
Time Frame: upto 72 hour post dose
to evaluate metabolic ratio of gemiglipin and rosuvastatin
upto 72 hour 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

April 1, 2013

Primary Completion (ACTUAL)

May 1, 2013

Study Completion (ACTUAL)

August 1, 2013

Study Registration Dates

First Submitted

March 28, 2013

First Submitted That Met QC Criteria

March 28, 2013

First Posted (ESTIMATE)

April 4, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

August 28, 2013

Last Update Submitted That Met QC Criteria

August 27, 2013

Last Verified

August 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LG-GSCL001

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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