Bioavailability Study of Two Formulations of Sarpogrelate HCl 300mg Tablets Under Fed Conditions
Study Details
Study Description
Brief Summary
A Single-dose, Comparative Bioavailability Study of Two Formulations of Sarpogrelate HCl 300mg Tablets Under Fed Conditions
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 1 |
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
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Anpl-one SR Tab. 300mg a single oral dose administration in healthy volunteers under fed condition |
Drug: Sarpogrelate HCL 300mg
a single oral dose administration in healthy volunteers under fed condition
|
Active Comparator: Sarpodipil SR Tab. 300mg a single oral dose administration in healthy volunteers under fed condition |
Drug: Sarpogrelate HCL 300mg
a single oral dose administration in healthy volunteers under fed condition
|
Outcome Measures
Primary Outcome Measures
- 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
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Daewoong pharmatceutical | Seoul | Korea, Republic of |
Sponsors and Collaborators
- Daewoong Pharmaceutical Co. LTD.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- DDS18-039BE