Sarpogrelate Drug Interaction

Hypertension Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02097511
• Other study ID #: DDI-102
• Status: Completed
• Phase: Phase 1
• First received: March 25, 2014
• Last updated: February 23, 2015
• Start date: December 2013
• Est. completion date: December 2014

Study information

• Verified date: February 2015
• Source: Ajou University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: December 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypertension
• Peripheral Arterial Disease
• Peripheral Artery Disease

Intervention

Drug:
• Sarpogrelate pretreatment
Sarpogrelate hydrochloride 100 mg pretreatment three times a day for three days
• Sarpogrelate
Sarpogrelate hydrochloride 100 mg three times a day
• Metoprolol
Metoprolol Tartrate 100 mg once a day

Locations

Country	Name	City	State
Korea, Republic of	Ajou University School of Medicine	Suwon	Gyeonggi

Sponsors (1)

Lead Sponsor	Collaborator
Ajou University School of Medicine

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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