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

NCT ID: NCT03947528

Last Updated: 2019-05-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-04
• Study Completion Date: 2019-05-13

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

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Anpl-one SR Tab. 300mg

a single oral dose administration in healthy volunteers under fed condition

Group Type: EXPERIMENTAL

Sarpogrelate HCL 300mg

Intervention Type: DRUG

a single oral dose administration in healthy volunteers under fed condition

Sarpodipil SR Tab. 300mg

a single oral dose administration in healthy volunteers under fed condition

Group Type: ACTIVE_COMPARATOR

Sarpogrelate HCL 300mg

Intervention Type: DRUG

a single oral dose administration in healthy volunteers under fed condition

Interventions

Sarpogrelate HCL 300mg

a single oral dose administration in healthy volunteers under fed condition

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Daewoong Pharmaceutical Co. LTD.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Daewoong pharmatceutical

Seoul, , South Korea

Countries

South Korea

Other Identifiers

DDS18-039BE

Identifier Type: -

Identifier Source: org_study_id