Clincosm LogoSign in Get a demo

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

Sponsor
Daewoong Pharmaceutical Co. LTD. (Industry)
Overall Status
Completed
CT.gov ID
NCT03574285
Collaborator
(none)
48
Enrollment
1
Location
2
Arms
4.4
Actual Duration (Months)
10.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Drug: Anpl-one SR Tab. 300mg
  • Drug: Sarpodipil SR Tab. 300mg
 Phase 1

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

Study Design

Study Type:
Interventional
Actual Enrollment :
48 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Single-dose, Comparative Bioavailability Study of Two Formulations of Sarpogrelate HCl 300mg Tablets Under Feeding Conditions
Actual Study Start Date :
May 31, 2018
Actual Primary Completion Date :
Aug 21, 2018
Actual Study Completion Date :
Oct 12, 2018

Arms and Interventions

Arm Intervention/Treatment
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
Anpl-one SR Tab. 300mg tablets followed by Sarpodipil SR Tab. 300mg tablets
Other Names:
  • Sarpogrelate HCl 300mg

    • Drug: Sarpodipil SR Tab. 300mg
    Sarpodipil SR Tab. 300mg tablets followed by Anpl-one SR Tab. 300mg tablets
    Other Names:
  • Sarpogrelate HCl 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
    Anpl-one SR Tab. 300mg tablets followed by Sarpodipil SR Tab. 300mg tablets
    Other Names:
  • Sarpogrelate HCl 300mg

    • Drug: Sarpodipil SR Tab. 300mg
    Sarpodipil SR Tab. 300mg tablets followed by Anpl-one SR Tab. 300mg tablets
    Other Names:
  • Sarpogrelate HCl 300mg

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Maximum Plasma Concentration [0-24hr]

      Cmax

    2. Area under the plasma concentration versus time curve [0-24hr]

      AUC

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years and Older
    Sexes Eligible for Study:
    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:
    • 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Deawoong pharmaceutical Seoul Gangnam-gu Korea, Republic of 06170

    Sponsors and Collaborators

    • Daewoong Pharmaceutical Co. LTD.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Daewoong Pharmaceutical Co. LTD.
    ClinicalTrials.gov Identifier:
    NCT03574285
    Other Study ID Numbers:
    • DDS17-035BE
    First Posted:
    Jun 29, 2018
    Last Update Posted:
    May 13, 2019
    Last Verified:
    May 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Sarpogrelate

    Study Results

    No Results Posted as of May 13, 2019