NCT03947489

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started Mar 2019

Shorter than P25 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 4, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 6, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 6, 2019

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

May 9, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 13, 2019

Completed
Last Updated

May 14, 2019

Status Verified

May 1, 2019

Enrollment Period

2 months

First QC Date

May 9, 2019

Last Update Submit

May 12, 2019

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

  • Maximum Plasma Concentration

    Maximum Plasma Concentration

    0~24hours

  • Area under the plasma concentration versus time curve

    Area under the plasma concentration versus time curve

    0~24hours

Study Arms (2)

Anpl-one SR Tab. 300mg

EXPERIMENTAL

a single oral dose administration in healthy volunteers under fasting condition

Drug: Sarpogrelate HCL 300mg

Sarpodipil SR Tab. 300mg

ACTIVE COMPARATOR

a single oral dose administration in healthy volunteers under fasting condition

Drug: Sarpogrelate HCL 300mg

Interventions

Sarpogrelate HCL 300mgDRUG

a single oral dose administration in healthy volunteers under fasting condition

Anpl-one SR Tab. 300mgSarpodipil SR Tab. 300mg

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Daewoong pharmatceutical

Seoul, South Korea

Location

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 9, 2019

First Posted

May 13, 2019

Study Start

March 4, 2019

Primary Completion

May 6, 2019

Study Completion

May 6, 2019

Last Updated

May 14, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)