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CompletedNCT03573622Updated May 13, 2019

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

A Phase 1 interventional study of Anpl-one SR Tab. 300mg and Sarpodipil SR Tab. 300mg in Healthy, sponsored by Daewoong Pharmaceutical Co. LTD.. Completed at 1 site in Korea, Republic of. Open to participants aged 19 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-05-13.

Sponsored by Daewoong Pharmaceutical Co. LTD. · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
62
Allocation
Randomized
Ages
19 Years and older
Sex
All
01

Study summary

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

Read the detailed description

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 volunteers under fasting condition: open label, single-dose, randomized, two-period, two-treatment, two-sequence, crossover, comparative bioavailability study

02

Conditions studied

  • Healthy
03

In context

Lead sponsor

Daewoong Pharmaceutical Co. LTD. is the lead sponsor of 196 studies on the registry; 33 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
62 participants (actual)

Study arms

  • Experimental
    Anpl-one SR Tab. 300mg

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

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

  • Active comparator
    Sarpodipil SR Tab. 300mg

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

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

Interventions

  • DrugAnpl-one SR Tab. 300mg

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

    Also known as: Sarpogrelate HCl 300mg

  • DrugSarpodipil SR Tab. 300mg

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

    Also known as: Sarpogrelate HCl 300mg

06

What researchers measure

Primary outcomes

  1. Maximum Plasma Concentration

    Cmax

    Time frame: 0-24hr

  2. Area under the plasma concentration versus time curve

    AUC

    Time frame: 0-24hr

07

Study locations

1 site
  • Daewoong pharmatceutical
    Seoul, Gangnam-gu 06170, Korea, Republic of
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 13, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03573622
Lead sponsor
Daewoong Pharmaceutical Co. LTD.
Responsible party
Sponsor
First posted
Jun 29, 2018
Start date
May 31, 2018
Primary completion
Aug 21, 2018
Completion
Oct 12, 2018
Last update
May 13, 2019

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2018. You cannot join it, but the record below documents what was studied.

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