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Completed

NCT Number: NCT03947489

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

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

Daewoong pharmatceutical

Seoul, South Korea

About this study

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

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

Sarpogrelate HCL 300mg

Drug

a single oral dose administration in healthy volunteers under fasting condition

Primary outcomes

  1. Maximum Plasma Concentration

    Time frame: 0~24hours

    Maximum Plasma Concentration

  2. Area under the plasma concentration versus time curve

    Time frame: 0~24hours

    Area under the plasma concentration versus time curve

Sponsors and collaborators

Lead sponsor

Daewoong Pharmaceutical Co. LTD.

Industry

Registry information

Official study title

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

Acronym: Sarpogrelate

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
May 13, 2019
Registry last updated
May 14, 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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