Sarpogrelate Drug Interaction

Ajou University School of Medicine

Status and phase

Completed

Phase 1

Conditions

Hypertension

Peripheral Artery Disease

Treatments

Drug: Metoprolol

Drug: Sarpogrelate

Drug: Sarpogrelate pretreatment

Study type

Interventional

Funder types

Other

Identifiers

NCT02097511

DDI-102

Details and patient eligibility

About

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

Full 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.

Enrollment

9 estimated patients

Sex

Male

Ages

20 to 45 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

9 participants in 3 patient groups

Sarpogrelate pretreatment and Metoprolol

Experimental group

Description:

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

Treatment:

Drug: Sarpogrelate

Drug: Metoprolol

Drug: Sarpogrelate pretreatment

Sarpogrelate and Metoprolol

Active Comparator group

Description:

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

Treatment:

Drug: Sarpogrelate

Drug: Metoprolol

Metoprolol only