Bioavailability Study of Two Formulations of Sarpogrelate HCl 300mg Tablets Under Fed Conditions
- Registration Number
- NCT03947528
- Lead Sponsor
- Daewoong Pharmaceutical Co. LTD.
- Brief Summary
A Single-dose, Comparative Bioavailability Study of Two Formulations of Sarpogrelate HCl 300mg Tablets Under Fed Conditions
- Detailed Description
To evaluate the bioequivalence of two formulations of Sarpogrelate HCl 300mg after a single oral dose administration in healthy volunteers under fed conditions
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 38
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Sarpodipil SR Tab. 300mg Sarpogrelate HCL 300mg a single oral dose administration in healthy volunteers under fed condition Anpl-one SR Tab. 300mg Sarpogrelate HCL 300mg a single oral dose administration in healthy volunteers under fed condition
- Primary Outcome Measures
Name Time Method Maximum Plasma Concentration 0~24hours Maximum Plasma Concentration
Area under the plasma concentration versus time curve 0~24hours Area under the plasma concentration versus time curve
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Daewoong pharmatceutical
🇰🇷Seoul, Korea, Republic of