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
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 9
- Locations
- 1
- Primary Endpoint
- Plasma concentration of Metoprolol and metabolites
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to 45 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Metoprolol only
Metoprolol Tartrate 100 mg once a day
Intervention: Metoprolol (Drug)
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
Intervention: Sarpogrelate pretreatment (Drug)
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
Intervention: Sarpogrelate (Drug)
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
Intervention: Metoprolol (Drug)
Sarpogrelate and Metoprolol
Metoprolol Tartrate 100 mg once a day with Sarpogrelate hydrochloride 100 mg three times a day
Intervention: Sarpogrelate (Drug)
Sarpogrelate and Metoprolol
Metoprolol Tartrate 100 mg once a day with Sarpogrelate hydrochloride 100 mg three times a day
Intervention: Metoprolol (Drug)
Outcomes
Primary Outcomes
Plasma concentration of Metoprolol and metabolites
Time Frame: 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 Outcomes
- Blood pressure and pulse rate changes(Upto 12 hours after Metoprolol Tartrate 100 mg dosing)
Investigators
Doo-Yeoun Cho
Assistant Professor
Ajou University School of Medicine