Healthy
Conditions
Brief summary
A Single-dose, Comparative Bioavailability Study of Two Formulations of Sarpogrelate HCl 300mg Tablets Under Fasting Conditions
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
Interventions
Anpl-one SR Tab. 300mg tablets followed by Sarpodipil SR Tab. 300mg tablets
Sarpodipil SR Tab. 300mg tablets followed by Anpl-one SR Tab. 300mg tablets
Sponsors
Daewoong Pharmaceutical Co. LTD.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
open label, single-dose, randomized, two-period, two-treatment, two-sequence, crossover, comparative bioavailability study
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Plasma Concentration | 0-24hr | Cmax |
| Area under the plasma concentration versus time curve | 0-24hr | AUC |
Countries
South Korea
Outcome results
None listed