A Single-dose, Comparative Bioavailability Study of Two Formulations of Sarpogrelate HCl 300mg Tablets Under Fasting Conditions
Study Details
Study Description
Brief Summary
A Single-dose, Comparative Bioavailability Study of Two Formulations of Sarpogrelate HCl 300mg Tablets Under Fasting Conditions
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 1 |
Detailed Description
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
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Anpl-one SR Tab. 300mg Anpl-one SR Tab. 300mg tablets followed by Sarpodipil SR Tab. 300mg tablets |
Drug: Anpl-one SR Tab. 300mg
Anpl-one SR Tab. 300mg tablets followed by Sarpodipil SR Tab. 300mg tablets
Other Names:
Drug: Sarpodipil SR Tab. 300mg
Sarpodipil SR Tab. 300mg tablets followed by Anpl-one SR Tab. 300mg tablets
Other Names:
|
Active Comparator: Sarpodipil SR Tab. 300mg Sarpodipil SR Tab. 300mg tablets followed by Anpl-one SR Tab. 300mg tablets |
Drug: Anpl-one SR Tab. 300mg
Anpl-one SR Tab. 300mg tablets followed by Sarpodipil SR Tab. 300mg tablets
Other Names:
Drug: Sarpodipil SR Tab. 300mg
Sarpodipil SR Tab. 300mg tablets followed by Anpl-one SR Tab. 300mg tablets
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Maximum Plasma Concentration [0-24hr]
Cmax
- Area under the plasma concentration versus time curve [0-24hr]
AUC
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 | Gangnam-gu | Korea, Republic of | 06170 |
Sponsors and Collaborators
- Daewoong Pharmaceutical Co. LTD.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- DDS17-034BE