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

Daewoong Pharmaceutical

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Sarpogrelate HCL 300mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT03947489

DDS18-038BE

Details and patient eligibility

About

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

Full description

To evaluate the bioequivalence of two formulations of Sarpogrelate HCl 300mg after a single oral dose administration in healthy volunteers under fasting conditions

Enrollment: 38 patients

Sex: All

Ages: 19+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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38 participants in 2 patient groups

Anpl-one SR Tab. 300mg

Experimental group

Description:

a single oral dose administration in healthy volunteers under fasting condition

Treatment:

Drug: Sarpogrelate HCL 300mg

Sarpodipil SR Tab. 300mg

Active Comparator group

Description:

a single oral dose administration in healthy volunteers under fasting condition

Treatment:

Drug: Sarpogrelate HCL 300mg