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Sarpogrelate Drug Interaction

Information source: Ajou University School of Medicine
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hypertension; Peripheral Artery Disease

Intervention: Sarpogrelate pretreatment (Drug); Sarpogrelate (Drug); Metoprolol (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Ajou University School of Medicine

Official(s) and/or principal investigator(s):
Doo-Yeoun Cho, MD, Principal Investigator, Affiliation: Ajou University School of Medicine

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

Clinical Details

Official title: 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

Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Plasma concentration of Metoprolol and metabolites

Secondary outcome: Blood pressure and pulse rate changes

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.

Eligibility

Minimum age: 20 Years. Maximum age: 45 Years. Gender(s): Male.

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

Locations and Contacts

Ajou University School of Medicine, Suwon, Gyeonggi 433-721, Korea, Republic of
Additional Information

Starting date: December 2013
Last updated: February 23, 2015

Page last updated: August 23, 2015

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