- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03573622
A Single-dose, Comparative Bioavailability Study of Two Formulations of Sarpogrelate HCl 300mg Tablets Under Fasting Conditions
May 9, 2019 updated by: Daewoong Pharmaceutical Co. LTD.
A Single-dose, Comparative Bioavailability Study of Two Formulations of Sarpogrelate HCl 300mg Tablets Under Fasting Conditions
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Study Type
Interventional
Enrollment (Actual)
62
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Gangnam-gu
-
Seoul, Gangnam-gu, Korea, Republic of, 06170
- Daewoong pharmatceutical
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Anpl-one SR Tab. 300mg
Anpl-one SR Tab.
300mg tablets followed by Sarpodipil SR Tab.
300mg tablets
|
Anpl-one SR Tab.
300mg tablets followed by Sarpodipil SR Tab.
300mg tablets
Other Names:
Sarpodipil SR Tab.
300mg tablets followed by Anpl-one SR Tab.
300mg tablets
Other Names:
|
Active Comparator: Sarpodipil SR Tab. 300mg
Sarpodipil SR Tab.
300mg tablets followed by Anpl-one SR Tab.
300mg tablets
|
Anpl-one SR Tab.
300mg tablets followed by Sarpodipil SR Tab.
300mg tablets
Other Names:
Sarpodipil SR Tab.
300mg tablets followed by Anpl-one SR Tab.
300mg tablets
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maximum Plasma Concentration
Time Frame: 0-24hr
|
Cmax
|
0-24hr
|
Area under the plasma concentration versus time curve
Time Frame: 0-24hr
|
AUC
|
0-24hr
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 31, 2018
Primary Completion (Actual)
August 21, 2018
Study Completion (Actual)
October 12, 2018
Study Registration Dates
First Submitted
June 19, 2018
First Submitted That Met QC Criteria
June 19, 2018
First Posted (Actual)
June 29, 2018
Study Record Updates
Last Update Posted (Actual)
May 13, 2019
Last Update Submitted That Met QC Criteria
May 9, 2019
Last Verified
June 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DDS17-034BE
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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