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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-31

Study Completion Date

2018-10-12

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Safety and Pharmacokinetic Characteristics of DP-R202 in Healthy Male Volunteers

NCT01421563

Healthy

COMPLETED PHASE1

Pharmacokinetic / Pharmacodynamic (PK/PD) Study of Multiple Doses of DP-R202 in Healthy Volunteers

NCT01429688

Healthy

COMPLETED PHASE1

SAFE (Sarpogrelate Anplone in Femoro-popliteal Artery Intervention Efficacy) Study

NCT02959606

Peripheral Arterial Disease

UNKNOWN PHASE4

To Evaluate the Lipid-Lowering Efficacy and Safety of Simvastatin 40 Mg Tablet In Patients With Hypercholesterolemia (0733-264)

NCT00398294

Hypercholesterolemia

COMPLETED PHASE4

Food Effect Study on Pharmacodynamic and Bioavailability of Clopidogrel 300/75 mg in Healthy Subjects

NCT01129271

Healthy

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

open label, single-dose, randomized, two-period, two-treatment, two-sequence, crossover, comparative bioavailability study

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Anpl-one SR Tab. 300mg

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

Group Type EXPERIMENTAL

Anpl-one SR Tab. 300mg

Intervention Type DRUG

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

Sarpodipil SR Tab. 300mg

Intervention Type DRUG

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

Sarpodipil SR Tab. 300mg

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

Group Type ACTIVE_COMPARATOR

Anpl-one SR Tab. 300mg

Intervention Type DRUG

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

Sarpodipil SR Tab. 300mg

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Anpl-one SR Tab. 300mg

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

Intervention Type DRUG

Sarpodipil SR Tab. 300mg

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

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Sarpogrelate HCl 300mg Sarpogrelate HCl 300mg

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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