Sarpogrelate Drug Interaction

NCT ID: NCT02097511

Last Updated: 2015-02-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-12-31
• Study Completion Date: 2014-12-31

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.

Conditions

Hypertension; Peripheral Artery Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Sarpogrelate pretreatment and Metoprolol

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

Group Type: EXPERIMENTAL

Sarpogrelate pretreatment

Intervention Type: DRUG

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

Sarpogrelate

Intervention Type: DRUG

Sarpogrelate hydrochloride 100 mg three times a day

Metoprolol

Intervention Type: DRUG

Metoprolol Tartrate 100 mg once a day

Sarpogrelate and Metoprolol

Metoprolol Tartrate 100 mg once a day with Sarpogrelate hydrochloride 100 mg three times a day

Group Type: ACTIVE_COMPARATOR

Sarpogrelate

Intervention Type: DRUG

Sarpogrelate hydrochloride 100 mg three times a day

Metoprolol

Intervention Type: DRUG

Metoprolol Tartrate 100 mg once a day

Metoprolol only

Metoprolol Tartrate 100 mg once a day

Group Type: ACTIVE_COMPARATOR

Metoprolol

Intervention Type: DRUG

Metoprolol Tartrate 100 mg once a day

Interventions

Sarpogrelate pretreatment

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

Intervention Type: DRUG

Sarpogrelate

Sarpogrelate hydrochloride 100 mg three times a day

Intervention Type: DRUG

Metoprolol

Metoprolol Tartrate 100 mg once a day

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Ajou University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Doo-Yeoun Cho

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Doo-Yeoun Cho, MD

Role: PRINCIPAL_INVESTIGATOR

Ajou University School of Medicine

Locations

Ajou University School of Medicine

Suwon, Gyeonggi-do, South Korea

Countries

South Korea

Other Identifiers

DDI-102

Identifier Type: -

Identifier Source: org_study_id