Ajou University School of Medicine
Suwon, Gyeonggi-do, 433-721, South Korea
NCT Number: NCT02097511
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
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Notify Me20 year–45 year
Male
Interventional
Phase 1
Suwon, Gyeonggi-do, 433-721, South Korea
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Sarpogrelate hydrochloride 100 mg pretreatment three times a day for three days
Sarpogrelate hydrochloride 100 mg three times a day
Metoprolol Tartrate 100 mg once a day
Time frame: 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
Time frame: 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
Ajou University School of Medicine
Other
A Randomized, Open-label, Three-sequence, Three-period Crossover Study to Investigate The Effect of Anplag on the Disposition of Betaloc in Healthy Male Volunteers
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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