Bioavailability Study of Two Formulations of Sarpogrelate HCl 300mg Tablets Under Fasting Conditions

• Sponsor: Daewoong Pharmaceutical Co. LTD. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03947489
• Collaborator: (none)
• Enrollment: 38
• Location: 1
• Arms: 2
• Actual Duration (Months): 2.1
• Patients Per Site Per Month: 18.4

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: Sarpogrelate HCL 300mg	Phase 1

Detailed Description

To evaluate the bioequivalence of two formulations of Sarpogrelate HCl 300mg after a single oral dose administration in healthy volunteers under fasting conditions

Study Design

• Study Type: Interventional
• Actual Enrollment: 38 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 Fasting Conditions
• Actual Study Start Date: Mar 4, 2019
• Actual Primary Completion Date: May 6, 2019
• Actual Study Completion Date: May 6, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Anpl-one SR Tab. 300mg a single oral dose administration in healthy volunteers under fasting condition	Drug: Sarpogrelate HCL 300mg; a single oral dose administration in healthy volunteers under fasting condition
Active Comparator: Sarpodipil SR Tab. 300mg a single oral dose administration in healthy volunteers under fasting condition	Drug: Sarpogrelate HCL 300mg; a single oral dose administration in healthy volunteers under fasting condition

Outcome Measures

Primary Outcome Measures

1. Maximum Plasma Concentration [0~24hours]

   Maximum Plasma Concentration

2. Area under the plasma concentration versus time curve [0~24hours]

   Area under the plasma concentration versus time curve

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	Daewoong pharmatceutical	Seoul		Korea, Republic of

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: NCT03947489
• Other Study ID Numbers: DDS18-038BE
• First Posted: May 13, 2019
• Last Update Posted: May 14, 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 14, 2019