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Validation of LC-MS/MS Method for Determination of Bivalirudin in Human Plasma: Application to a Pharmacokinetic Study

Kim YH, Park HJ, Choi HY, Lim HS, Bae KS

BACKGROUND: Bivalirudin is a direct thrombin inhibitor for patients with unstable angina undergoing percutaneous coronary intervention. METHODS: A sensitive liquid chromatography-tandem mass spectrometry (LC/MS/MS) method was developed and validated for the...
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Bioequivalence of Two Erlotinib Formulations in Healthy Volunteers

Kim J, Jin EH, Choi YW, Min BG, Lee BH, Chung JS, Nam KY, Jung WT, Kim SH, Lee HJ, Hong JH

BACKGROUND: Erlotinib is a tyrosine kinase inhibitor prescribed for the treatment of non-small cell lung cancer and pancreatic cancer. The aim of this study was to compare the safety and...
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Pharmacokinetics of T-614 after Single Oral Administration in Healthy Korean Volunteers

Shin D, Kim BH, Kim JR, Lim KS, Jang IJ, Shin SG, Yu KS

BACKGROUND: Iguratimod is a new type of disease modifying anti-rheumatic drug, which reduced the production of inflammatory cytokines. The purpose of this study was to evaluate pharmacokinetic characteristics and safety...
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Pharmacokinetics, Pharmacodynamics and Safety of JES9501 after Single and Multiple Oral Administration in Healthy Subjects

Kim A, Kim BH, Shin D, Cho JY, Yu KS, Jang IJ, Chung JY

BACKGROUND: JES9501 is dehydroevodiamine, the extract of Evodia rutaecarpa, expected to be a new therapeutic for Alzheimer disease. This study aims to investigate the pharmacokinetics (PK), pharmacodynamics (PD) and safety...
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Steady-State Pharmacokinetic Properties of Tamsulosin in Healthy Male Volunteers

Seong SJ, Lee HW, Lee J, Lim MS, Kim EH, Park SM, Gwon MR, Yoon YR

BACKGROUND: To evaluate the pharmacokinetic properties of daily oral doses of tamsulosin administered to fasted healthy Korean male volunteers for 5 days. METHODS: In a randomized, open-label, multiple-dose, two-period, crossover study,...
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Bioequivalence of HCP1104, a New Fixed Dose Combination Drug and Co-administration of Eperisone 50 mg and Aceclofenac 100 mg: A Partial Replicated Crossover Study Design to Estimate the Pharmacokinetics of Highly Variable Drugs

Kim MJ, Kim YH, Choi HY, Jeon HS, Noh YH, Lim HS, Bae KS

BACKGROUND: This clinical study was conducted to compare pharmacokinetics of eperisone and aceclofenac of HCP1104, a new fixed dose combination drug with those in co-administration of eperisone 50 mg and...
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Pharmacokinetics and Safety of Levodropropizine Controlled Release Tablet after Repeated Dosing in Healthy Male Volunteers

Jeon S, Lee J, Hong T, Paek J, Han S, Yim DS

BACKGROUND: Levodropropizine is non-opioid agent whose peripheral antitussive action may result from its modulation of sensory neuropeptide levels. Currently, levodropropizine 60 mg is taken three-times daily. A controlled release formulation...
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Pharmacokinetic Characteristics of Cefcapene Pivoxil Hydrochloride after Single Oral Administration in Healthy Korean Subjects

Rhee SJ, Shin KH, Cha YJ, Kim JR, Oh DS, Cho JY, Yu KS, Jang IJ, Chung JY, Lim KS

BACKGROUND: Cefcapene pivoxil hydrochloride (CFPN-PI) is an oral ester cephalosporin antibiotic with a broad spectrum. In this study, we investigated the pharmacokinetics (PK) and tolerability of CFPN-PI following single oral...
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Comparison of Pharmacokinetic Characteristics and Safety Between JW Amlodipine(R) Tablet 5 mg and Novarsc(R) Tablet 5 mg in Healthy Male Volunteers

Kim YH, Lim HS, Cho SH, Ghim JL, Choe S, Jung JA, Bae KS

BACKGROUND: Amlodipine is a third-generation dihydropyridine calcium channel blocker, which has proven to be a useful drug against hypertension or angina. METHODS: This randomized, open-label, two-period, two-treatment, single-dose, crossover study was...
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