Sarpogrelate Drug Interaction

Phase 1CompletedNCT02097511

Ajou University School of Medicine9 enrolled

Overview

This is a randomized, open-label, single \& multiple-dose, three-sequence, three-period crossover study to investigate the effect of sarpogrelate hydrochloride on the disposition of metoprolol tartrate in healthy male volunteers

Eligibility for participation of this study will be determined from demographic information, medical history, physical examination, electrocardiogram (ECG) and clinical laboratory tests within 4 weeks before study drug administration. Subjects suitable for this study will be admitted to the Clinical Trial Center of Ajou University Medical Center on the day before dosing (Day -1). On Day 1, Subjects will be dosed study drug (metoprolol tartrate 100 mg once a day only, or metoprolol tartrate 100 mg once a day with sarpogrelate hydrochloride 100 mg three times a day, sarpogrelate hydrochloride 100 mg three times a day pretreatment for three days and metoprolol tartrate 100 mg once a day with sarpogrelate hydrochloride 100 mg three times a day). Pharmacokinetic samplings and blood pressure/pulse rate measurement will be done upto 12 hours after metoprolol tartrate 100 mg dosing. After one week of washout period (Day 8), Subjects will be dosed study drug by crossover manner, and pharmacokinetic samplings and blood pressure/pulse rate measurement will be done upto 12 hours after metoprolol tartrate 100 mg dosing. After one week of washout period (Day 15), Subjects will be dosed study drug by crossover manner, and pharmacokinetic samplings and blood pressure/pulse rate measurement will be done upto 12 hours after metoprolol tartrate 100 mg dosing.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hypertension Peripheral Artery Disease

Interventions

Sarpogrelate pretreatmentDRUG

Sarpogrelate hydrochloride 100 mg pretreatment three times a day for three days

SarpogrelateDRUG

Sarpogrelate hydrochloride 100 mg three times a day

MetoprololDRUG

Metoprolol Tartrate 100 mg once a day

Eligibility

Sex: MALEMin age: 20 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy male subjects aged 20 - 45 years * With in 20% of ideal body weight, {Ideal body weight=\[height(cm)-100\]\*0.9} * Agreement with written informed consent Exclusion Criteria: * Clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal disease or mental disorder (Past history or present) * Inadequate result of laboratory test (especially, AST/ALT \> 1.25 x UNL, Total bilirubin \> 1.5 x UNL) * Positive reaction in the HBs Ag, anti-HCV Ab, anti-HIV Ab, VDRL test * Taking OTC(Over the counter)medicine including oriental medicine within 7 days * Clinically significant allergic disease (Except for mild allergic rhinitis and dermatitis seems to be not need for medication) * Subject with known for hypersensitivity reaction to Metoprolol or Sarpogrelate * Previous whole blood donation within 60 days or component blood donation within 30 days * Previous participation of other trial within 90 days * Continued taking caffeine (caffeine \> 5 cup/day), drinking (alcohol \> 30 g/day) and severe heavy smoker (cigarette \> 1/2 pack per day) * An impossible one who participates in clinical trial by investigator's decision including for reason of laboratory test result

Locations (1)

Ajou University School of Medicine

Suwon, Gyeonggi-do, South Korea

Outcomes

Primary Outcomes

Plasma concentration of Metoprolol and metabolites

Cmax (maximal plasma concentration) and AUC (area under the time-concentration curve) will be calculated from pharmacokinetic samplings

Time frame: upto 12 hours after Metoprolol Tartrate 100 mg dosing

Secondary Outcomes

Blood pressure and pulse rate changes

Blood pressure and pulse rate measurement with Dash 5000 patient monitoring system (GE Healthcare, USA) at 0 (before Metoprolol Tartrate 100 mg dosing), 1, 2, 3, 4, 5, 6, 8, 10, 12 hours after Metoprolol Tartrate 100 mg dosing

Time frame: Upto 12 hours after Metoprolol Tartrate 100 mg dosing

Data from ClinicalTrials.gov

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