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Bioavailability Study of Two Formulations of Sarpogrelate HCl 300mg Tablets Under Fed Conditions (Sarpogrelate)

Primary Purpose

Healthy

Status
Unknown status
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Sarpogrelate HCL 300mg
Sponsored by
Daewoong Pharmaceutical Co. LTD.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Healthy

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • Daewoong pharmatceutical

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Anpl-one SR Tab. 300mg

Sarpodipil SR Tab. 300mg

Arm Description

a single oral dose administration in healthy volunteers under fed condition

a single oral dose administration in healthy volunteers under fed condition

Outcomes

Primary Outcome Measures

Maximum Plasma Concentration
Maximum Plasma Concentration
Area under the plasma concentration versus time curve
Area under the plasma concentration versus time curve

Secondary Outcome Measures

Full Information

First Posted
May 9, 2019
Last Updated
May 12, 2019
Sponsor
Daewoong Pharmaceutical Co. LTD.
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1. Study Identification

Unique Protocol Identification Number
NCT03947528
Brief Title
Bioavailability Study of Two Formulations of Sarpogrelate HCl 300mg Tablets Under Fed Conditions
Acronym
Sarpogrelate
Official Title
A Single-dose, Comparative Bioavailability Study of Two Formulations of Sarpogrelate HCl 300mg Tablets Under Fed Conditions
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Unknown status
Study Start Date
March 4, 2019 (Actual)
Primary Completion Date
May 13, 2019 (Anticipated)
Study Completion Date
May 13, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Daewoong Pharmaceutical Co. LTD.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
A Single-dose, Comparative Bioavailability Study of Two Formulations of Sarpogrelate HCl 300mg Tablets Under Fed Conditions
Detailed Description
To evaluate the bioequivalence of two formulations of Sarpogrelate HCl 300mg after a single oral dose administration in healthy volunteers under fed conditions

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Anpl-one SR Tab. 300mg
Arm Type
Experimental
Arm Description
a single oral dose administration in healthy volunteers under fed condition
Arm Title
Sarpodipil SR Tab. 300mg
Arm Type
Active Comparator
Arm Description
a single oral dose administration in healthy volunteers under fed condition
Intervention Type
Drug
Intervention Name(s)
Sarpogrelate HCL 300mg
Intervention Description
a single oral dose administration in healthy volunteers under fed condition
Primary Outcome Measure Information:
Title
Maximum Plasma Concentration
Description
Maximum Plasma Concentration
Time Frame
0~24hours
Title
Area under the plasma concentration versus time curve
Description
Area under the plasma concentration versus time curve
Time Frame
0~24hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Daewoong pharmatceutical
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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