Hypertension, Peripheral Artery Disease
Conditions
Keywords
Drug-drug interaction, Pharmacokinetics, Pharmacodynamics
Brief summary
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
Detailed description
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.
Interventions
DRUGSarpogrelate pretreatment
Sarpogrelate hydrochloride 100 mg pretreatment three times a day for three days
DRUGSarpogrelate
Sarpogrelate hydrochloride 100 mg three times a day
DRUGMetoprolol
Metoprolol Tartrate 100 mg once a day
Sponsors
Ajou University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
20 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Plasma concentration of Metoprolol and metabolites | upto 12 hours after Metoprolol Tartrate 100 mg dosing | Cmax (maximal plasma concentration) and AUC (area under the time-concentration curve) will be calculated from pharmacokinetic samplings |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Blood pressure and pulse rate changes | Upto 12 hours after Metoprolol Tartrate 100 mg dosing | 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 |
Countries
South Korea
Outcome results
None listed