A Single-dose, Comparative 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: Sarpodipil SR Tab. 300mg; Drug: Anpl-one SR Tab. 300mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT03573622

DDS17-034BE

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, 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

Enrollment: 62 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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62 participants in 2 patient groups

Anpl-one SR Tab. 300mg

Experimental group

Description:

Anpl-one SR Tab. 300mg tablets followed by Sarpodipil SR Tab. 300mg tablets

Treatment:

Drug: Anpl-one SR Tab. 300mg

Drug: Sarpodipil SR Tab. 300mg

Sarpodipil SR Tab. 300mg

Active Comparator group

Description:

Sarpodipil SR Tab. 300mg tablets followed by Anpl-one SR Tab. 300mg tablets

Treatment:

Drug: Anpl-one SR Tab. 300mg

Drug: Sarpodipil SR Tab. 300mg