Sarpogrelate Drug Interaction

Phase 1

Completed

• Conditions: Hypertension; Peripheral Artery Disease
• Interventions: Drug: Sarpogrelate pretreatment; Drug: Metoprolol; Drug: Sarpogrelate

• Registration Number: NCT02097511
• Lead Sponsor: Ajou University School of Medicine

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.

Study Timeline

• Study Start: 2013-12
• Primary Completion: 2014-01
• Study First Submitted: 2014-03-25
• Study First Submitted QC: 2014-03-25
• Study First Posted: 2014-03-27
• Study Completion: 2014-12
• Status Verified: 2015-02
• Last Update Submitted: 2015-02-23
• Last Update Posted: 2015-02-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 9

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sarpogrelate pretreatment and Metoprolol	Sarpogrelate pretreatment	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	Metoprolol	Metoprolol Tartrate 100 mg once a day with Sarpogrelate hydrochloride 100 mg three times a day
Sarpogrelate pretreatment and Metoprolol	Sarpogrelate	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 pretreatment and Metoprolol	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
Sarpogrelate and Metoprolol	Sarpogrelate	Metoprolol Tartrate 100 mg once a day with Sarpogrelate hydrochloride 100 mg three times a day
Metoprolol only	Metoprolol	Metoprolol Tartrate 100 mg once a day

Primary Outcome Measures

Name	Time	Method
Plasma concentration of Metoprolol and metabolites	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

Secondary Outcome Measures

Name	Time	Method
Blood pressure and pulse rate changes	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

Trial Locations

Locations (1)

Ajou University School of Medicine; 🇰🇷 Suwon, Gyeonggi, Korea, Republic of