Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sarpogrelate pretreatment and Metoprolol | Experimental | Sarpogrelate hydrochloride 100 mg pretreatment three times a day for three days and Metoprolol Tartrate 100 mg once a day with Sarpogrelate hydrochloride 100 mg three times a day |
|
| Sarpogrelate and Metoprolol | Active Comparator | Metoprolol Tartrate 100 mg once a day with Sarpogrelate hydrochloride 100 mg three times a day |
|
| Metoprolol only | Active Comparator | Metoprolol Tartrate 100 mg once a day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sarpogrelate pretreatment | Drug | Sarpogrelate hydrochloride 100 mg pretreatment three times a day for three days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Plasma concentration of Metoprolol and metabolites | Cmax (maximal plasma concentration) and AUC (area under the time-concentration curve) will be calculated from pharmacokinetic samplings | upto 12 hours after Metoprolol Tartrate 100 mg dosing |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Upto 12 hours after Metoprolol Tartrate 100 mg dosing |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Doo-Yeoun Cho, MD | Ajou University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ajou University School of Medicine | Suwon | Gyeonggi-do | 433-721 | South Korea |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Apr 23, 2015 | |
| Reset | May 7, 2015 |
Not provided
Not provided
| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 23, 2015 | May 7, 2015 |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| D058729 | Peripheral Arterial Disease |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
Not provided
Not provided
| ID | Term |
|---|---|
| C064294 | sarpogrelate |
| D008790 | Metoprolol |
| ID | Term |
|---|---|
| D050198 | Phenoxypropanolamines |
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Sarpogrelate | Drug | Sarpogrelate hydrochloride 100 mg three times a day |
|
| Metoprolol | Drug | Metoprolol Tartrate 100 mg once a day |
|
| D001157 |
| Arterial Occlusive Diseases |
| D016491 | Peripheral Vascular Diseases |
| D009930 |
| Organic Chemicals |
| D020005 | Propanols |
| D000588 | Amines |