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NCT03947528 Clinical Trial

Bioavailability Study of Two Formulations of Sarpogrelate HCl 300mg Tablets Under Fed Conditions

Healthy Clinical Trial

— Sarpogrelate  

Official title:
A Single-dose, Comparative Bioavailability Study of Two Formulations of Sarpogrelate HCl 300mg Tablets Under Fed Conditions

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT03947528
Other study ID # DDS18-039BE
Secondary ID
Status Active, not recruiting
Phase Phase 1
First received
Last updated
Start date March 4, 2019
Est. completion date May 13, 2019

Study information
Verified date May 2019
Source Daewoong Pharmaceutical Co. LTD.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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 information / eligibility
Status Active, not recruiting
Enrollment 38
Est. completion date May 13, 2019
Est. primary completion date May 13, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 19 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• Sarpogrelate HCL 300mg
a single oral dose administration in healthy volunteers under fed condition

Locations
Country Name City State
Korea, Republic of Daewoong pharmatceutical Seoul

Sponsors (1)
Lead Sponsor Collaborator
Daewoong Pharmaceutical Co. LTD.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Maximum Plasma Concentration Maximum Plasma Concentration 0~24hours
Primary Area under the plasma concentration versus time curve Area under the plasma concentration versus time curve 0~24hours
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