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Pharmacokinetic/Pharmacodynamic Drug-drug Interaction of LC15-0444 and Metformin After Oral Administration in Healthy Male Subjects

NCT ID: NCT01426399

Last Updated: 2011-12-30

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

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2011-12-31

Brief Summary

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The objective of the study was to investigate the drug-drug interaction between LC15-0444 and metformin by comparing the pharmacokinetic/pharmacodynamic, safety, tolerability in healthy male subjets after oral administration concomitantly and each alone.

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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LC15-0444

LC15-0444 50mg qd

Group Type EXPERIMENTAL

LC15-0444

Intervention Type DRUG

LC15-0444 50mg qd (8 days once daily)

Metformin

Metformin 1000mg bid

Group Type EXPERIMENTAL

Metformin

Intervention Type DRUG

Metformin 1000 mg bid (8 days twice daily)

LC15-0444+Metformin

LC15-0444 50mg qd +Metformin 1000mg bid

Group Type EXPERIMENTAL

LC15-0444+Metformin

Intervention Type DRUG

LC15-0444 50mg qd (8 days once daily) + Metformin 1000 mg bid (8 days twice daily)

Interventions

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LC15-0444

LC15-0444 50mg qd (8 days once daily)

Intervention Type DRUG

Metformin

Metformin 1000 mg bid (8 days twice daily)

Intervention Type DRUG

LC15-0444+Metformin

LC15-0444 50mg qd (8 days once daily) + Metformin 1000 mg bid (8 days twice daily)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Age between 20 to 45, healthy male subjects(at screening)
* Body weight between 55kg - 90kg, BMI between 18.0 - 27.0
* 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 progress.

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.(Aspirin, antibiotics)
* Subject who already participated in other trials in 2months
* Subject who had whole blood donation in 2months, or component blood donation in 1months or transfusion in 1months currently.
* Smokers.(but, if the subject did'nt smoke in 3months, can participate the trial)
Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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LG Life Sciences

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kyung-sang Yu, M.D,Ph.D

Role: PRINCIPAL_INVESTIGATOR

Seoul national univ. hospital

Locations

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Seoul National University Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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Shin D, Cho YM, Lee S, Lim KS, Kim JA, Ahn JY, Cho JY, Lee H, Jang IJ, Yu KS. Pharmacokinetic and pharmacodynamic interaction between gemigliptin and metformin in healthy subjects. Clin Drug Investig. 2014 Jun;34(6):383-93. doi: 10.1007/s40261-014-0184-3.

Reference Type DERIVED
PMID: 24627290 (View on PubMed)

Other Identifiers

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LG-DPCL009

Identifier Type: -

Identifier Source: org_study_id