A Single-dose, Comparative Bioavailability Study of Two Formulations of Sarpogrelate HCl 300mg Tablets Under Fasting Conditions

Study Overview
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Brief Summary
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A Single-dose, Comparative Bioavailability Study of Two Formulations of Sarpogrelate HCl 300mg Tablets Under Fasting Conditions

Detailed Description
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To evaluate the bioequivalence of two formulations of Sarpogrelate HCl 300mg, Anpl-one SR Tab. 300mg (Reference) and generic Sarpogrelate HCl 300mg (Test), after a single oral dose administration in healthy volunteers under fasting condition: open label, single-dose, randomized, two-period, two-treatment, two-sequence, crossover, comparative bioavailability study

Official Title
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A Single-dose, Comparative Bioavailability Study of Two Formulations of Sarpogrelate HCl 300mg Tablets Under Fasting Conditions

Conditions
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Healthy

Intervention / Treatment
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* Drug: Anpl-one SR Tab. 300mg
* Drug: Sarpodipil SR Tab. 300mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy, non-smoking, male and female subjects, 19 years of age or older BMI ≥ 18.0 and ≤ 30.0 kg/m2. Females who participate in this study will be of childbearing or non-childbearing potential Exclusion Criteria: Know history or presence of clinically significant neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, genitourinary, psychiatric, or cardiovascular disease or any other condition which, in the opinion of the investigator, would jeopardized the safety of the subject or impact the validity of the study results

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: open label, single-dose, randomized, two-period, two-treatment, two-sequence, crossover, comparative bioavailability study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Anpl-one SR Tab. 300mg<br>Anpl-one SR Tab. 300mg tablets followed by Sarpodipil SR Tab. 300mg tablets | Drug: Anpl-one SR Tab. 300mg<br>* Anpl-one SR Tab. 300mg tablets followed by Sarpodipil SR Tab. 300mg tablets<br>* Other names: Sarpogrelate HCl 300mg;Drug: Sarpodipil SR Tab. 300mg<br>* Sarpodipil SR Tab. 300mg tablets followed by Anpl-one SR Tab. 300mg tablets<br>* Other names: Sarpogrelate HCl 300mg;|
| Active Comparator: Sarpodipil SR Tab. 300mg<br>Sarpodipil SR Tab. 300mg tablets followed by Anpl-one SR Tab. 300mg tablets | Drug: Anpl-one SR Tab. 300mg<br>* Anpl-one SR Tab. 300mg tablets followed by Sarpodipil SR Tab. 300mg tablets<br>* Other names: Sarpogrelate HCl 300mg;Drug: Sarpodipil SR Tab. 300mg<br>* Sarpodipil SR Tab. 300mg tablets followed by Anpl-one SR Tab. 300mg tablets<br>* Other names: Sarpogrelate HCl 300mg;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum Plasma Concentration | Cmax | 0-24hr | 
| Area under the plasma concentration versus time curve | AUC | 0-24hr |