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

May 9, 2019 updated by: Daewoong Pharmaceutical Co. LTD.
A Single-dose, Comparative Bioavailability Study of Two Formulations of Sarpogrelate HCl 300mg Tablets Under Feeding Conditions

Study Overview

Status

Completed

Conditions

Detailed 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 Thai volunteers under feeding condition: open label, single-dose, randomized, two-period, two-treatment, two-sequence, crossover, comparative bioavailability study

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Gangnam-gu
      • Seoul, Gangnam-gu, Korea, Republic of, 06170
        • Deawoong pharmaceutical

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Anpl-one SR Tab. 300mg
Anpl-one SR Tab. 300mg tablets followed by Sarpodipil SR Tab. 300mg tablets
Anpl-one SR Tab. 300mg tablets followed by Sarpodipil SR Tab. 300mg tablets
Other Names:
  • Sarpogrelate HCl 300mg
Sarpodipil SR Tab. 300mg tablets followed by Anpl-one SR Tab. 300mg tablets
Other Names:
  • Sarpogrelate HCl 300mg
ACTIVE_COMPARATOR: Sarpodipil SR Tab. 300mg
Sarpodipil SR Tab. 300mg tablets followed by Anpl-one SR Tab. 300mg tablets
Anpl-one SR Tab. 300mg tablets followed by Sarpodipil SR Tab. 300mg tablets
Other Names:
  • Sarpogrelate HCl 300mg
Sarpodipil SR Tab. 300mg tablets followed by Anpl-one SR Tab. 300mg tablets
Other Names:
  • Sarpogrelate HCl 300mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum Plasma Concentration
Time Frame: 0-24hr
Cmax
0-24hr
Area under the plasma concentration versus time curve
Time Frame: 0-24hr
AUC
0-24hr

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 31, 2018

Primary Completion (ACTUAL)

August 21, 2018

Study Completion (ACTUAL)

October 12, 2018

Study Registration Dates

First Submitted

June 20, 2018

First Submitted That Met QC Criteria

June 28, 2018

First Posted (ACTUAL)

June 29, 2018

Study Record Updates

Last Update Posted (ACTUAL)

May 13, 2019

Last Update Submitted That Met QC Criteria

May 9, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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