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Completed

NCT Number: NCT03574285

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

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

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Key information

Conditions

Healthy

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Deawoong pharmaceutical

Seoul, Gangnam-gu, 06170, South Korea

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Anpl-one SR Tab. 300mg

Drug

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

Other names: Sarpogrelate HCl 300mg

Sarpodipil SR Tab. 300mg

Drug

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

Other names: Sarpogrelate HCl 300mg

Primary outcomes

  1. Maximum Plasma Concentration

    Time frame: 0-24hr

    Cmax

  2. Area under the plasma concentration versus time curve

    Time frame: 0-24hr

    AUC

Sponsors and collaborators

Lead sponsor

Daewoong Pharmaceutical Co. LTD.

Industry

Registry information

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jun 29, 2018
Registry last updated
May 13, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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