NCT03573622

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
62

participants targeted

Target at P75+ for phase_1 healthy

Timeline
Completed

Started May 2018

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

May 31, 2018

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

June 19, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 29, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 21, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 12, 2018

Completed
Last Updated

May 13, 2019

Status Verified

June 1, 2018

Enrollment Period

3 months

First QC Date

June 19, 2018

Last Update Submit

May 9, 2019

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

  • Maximum Plasma Concentration

    Cmax

    0-24hr

  • Area under the plasma concentration versus time curve

    AUC

    0-24hr

Study Arms (2)

Anpl-one SR Tab. 300mg

EXPERIMENTAL

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

Drug: Anpl-one SR Tab. 300mgDrug: Sarpodipil SR Tab. 300mg

Sarpodipil SR Tab. 300mg

ACTIVE COMPARATOR

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

Drug: Anpl-one SR Tab. 300mgDrug: Sarpodipil SR Tab. 300mg

Interventions

Anpl-one SR Tab. 300mgDRUG

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

Also known as: Sarpogrelate HCl 300mg
Anpl-one SR Tab. 300mgSarpodipil SR Tab. 300mg
Sarpodipil SR Tab. 300mgDRUG

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

Also known as: Sarpogrelate HCl 300mg
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, Gangnam-gu, 06170, South Korea

Location

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: open label, single-dose, randomized, two-period, two-treatment, two-sequence, crossover, comparative bioavailability study
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 19, 2018

First Posted

June 29, 2018

Study Start

May 31, 2018

Primary Completion

August 21, 2018

Study Completion

October 12, 2018

Last Updated

May 13, 2019

Record last verified: 2018-06

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)